---
type: "firecrawl-provider"
description: "US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book."
use_when: "US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.\n\nUS FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.\n\nUS FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.\n\nUS FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.\n\nUS FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.\n\nUS FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.\n\nUS FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book."
categories: "Life sciences"
capabilities: 27
credits_per_call: 5
---
# FDA on Firecrawl Alexandria

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

- Categories: Life sciences
- Category index: [Life sciences category](https://alexandria.firecrawl.dev/agents/categories/life-sciences)
- Provider key: `fda-gov`
- Access: Firecrawl credits
- Cost: 5 credits per call

## More

- [Human guide](https://www.firecrawl.dev/app/alexandria/fda-gov)
- [OpenAPI spec](https://alexandria.firecrawl.dev/agents/providers/fda-gov/openapi.json)

## Capabilities

- [Complete response letter](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/complete_response_letter): Read one FDA complete response letter in full from openFDA: the fields complete_response_letters returns plus the letter's OCR text and a list of the application's other published CRLs. Without letter_date it returns the application's most recent letter.
- [Complete response letters](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/complete_response_letters): Search FDA complete response letters (CRLs), the letters FDA sends when it will not approve an NDA or BLA as submitted, as published in openFDA. Filter by letter date range, words in the letter, company, application number and whether the application was later approved; newest first. Each letter has its date, type, company, application numbers, review office and signatory, the letter's own section headings, a short excerpt and the PDF link. FDA publishes CRLs in batches, so last_updated is the dataset date and a letter a sponsor has announced may not be published yet.
- [Device clearances](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/device_clearances): Search device 510(k) submission decision records and resolve a k_number. Preserve decision_code and decision_date; do not equate every returned submission with clearance or PMA approval.
- [Device recalls](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/device_recalls): Search medical device enforcement recall records and resolve a recall_number. Preserve recall reason, status and classification; this is not the separate device recall classification dataset.
- [Drug application documents](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_application_documents): Drugs@FDA documents for one NDA, ANDA or BLA: approval and action letters, labels, reviews, summary reviews, medication guides and other documents with type, date and URL, newest first, each with its submission (type, number, status, status date, class). Read from openFDA's Drugs@FDA dataset, whose documents match the Drugs@FDA application page. A document's presence is not proof that the product is currently approved or marketed.
- [Drug applications](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_applications): Search Drugs@FDA applications and submission histories, or resolve an application_number. Inspect submission statuses: a returned record alone is not proof of current approval or availability.
- [Drug events](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_events): FAERS drug adverse event reports: patient reactions, suspect and concomitant drugs, seriousness and reporter qualification. Search e.g. patient.drug.medicinalproduct:aspirin, patient.reaction.reactionmeddrapt:nausea or receivedate:[20250101 TO 20251231], or resolve a safetyreportid using record_id. A report is not evidence that the drug caused the reaction; FAERS lags the calendar by months.
- [Drug labels](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_labels): Search structured drug labeling and resolve a source label id. Includes source warnings and indications where available. Label presence does not itself establish FDA approval.
- [Drug ndc](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_ndc): NDC Directory product listings: product NDC, brand and generic names, labeler, dosage form, route, active ingredients, marketing category and packages. Search e.g. brand_name:Lipitor, generic_name:atorvastatin or labeler_name:Pfizer, or resolve a product_ndc using record_id. A listing is not proof of FDA approval.
- [Drug recalls](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_recalls): Search drug enforcement recall records, including classification, reason and recall status. Search product_description, recalling_firm or report_date, or resolve a recall_number using record_id.
- [Drug shortages](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_shortages): FDA drug shortage entries: generic name, company, presentation, status (Current, Resolved, To Be Discontinued), therapeutic category and posting and update dates. Search e.g. generic_name:amoxicillin, status:Current or company_name:Pfizer, or resolve a package_ndc using record_id; one package NDC can appear in more than one entry.
- [Food recalls](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/food_recalls): Search food enforcement recall records and resolve a recall_number. Source recall status and affected product descriptions are preserved.
- [Orange book](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/orange_book): Orange Book products for one application, active ingredient or trade name, each with therapeutic equivalence (TE) codes, RLD and reference-standard flags, approval date, listed patents (expiry, drug substance and product flags, every patent use code, delist request) and exclusivities with expiry. Products come from openFDA's Orange Book API; patents and exclusivities come from FDA's monthly Orange Book data file, read by byte range, because openFDA keeps only one use code per patent. A listed patent is the applicant's submission, not a finding on validity or infringement.
- [Orphan designation](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/orphan_designation): Read one FDA orphan drug designation by its OOPD key or a pasted OOPD detail-page URL, with the fields orphan_designations returns: designation and date, sponsor and country, status, withdrawal date and every orphan approval with approved indication and exclusivity end date.
- [Orphan designations](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/orphan_designations): Search FDA orphan drug designations and orphan approvals in the Office of Orphan Products Development database by product (generic or trade name), sponsor, designated disease or condition, designation dates, approval dates and status. Each designation has its text and date, sponsor and country, status, withdrawal date and every orphan approval with approved indication, exclusivity end date and exclusivity-protected indication. Newest designation first, or newest approval first when filtered by approval dates; with approval dates, approvals lists only those in the window.
- [Warning letter](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/warning_letter): Read one FDA warning letter, or a posted close-out or response letter, from fda.gov: company, MARCS-CMS case number, letter date, issuing office, delivery method, regulated products, the recipient and office header blocks, and the full letter text as plain paragraphs.
- [Warning letters](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/warning_letters): Search FDA warning letters posted on fda.gov: company, letter issue and posted dates, issuing office, subject, links to any posted response or close-out letter, and a matching excerpt. Filter by full-text query (company, subject or letter text), issuing office, issue year, or letters issued or posted in the last 7, 30, 60 or 90 days. The fda.gov listing holds letters posted since January 2021; older letters are in FDA's archive and not searched.
- [Cell gene therapies](https://alexandria.firecrawl.dev/agents/providers/fda-gov/biologics/cell_gene_therapies): List CBER's approved cellular and gene therapy products, the list FDA maintains, joined to the CBER BLAs in the Purple Book's monthly data file: product and trade name, proper name, manufacturer, FDA product page, first approval date, and per BLA the applicant, proprietary names, licensure, reference product and orphan exclusivity end dates. Newest approval first.
- [Purple book](https://alexandria.firecrawl.dev/agents/providers/fda-gov/biologics/purple_book): Search the Purple Book, FDA's database of licensed biological products (CDER and CBER), from its latest monthly data file. One row per BLA: applicant, proper and proprietary names, license types (351(a) reference product, 351(k) biosimilar or interchangeable), the reference product a biosimilar cites, first approval date, date of first licensure, reference product, first interchangeable and orphan exclusivity end dates, whether a patent list was provided, and every licensed presentation with strength, dosage form, route, marketing status and approval dates. Newest first approval first.
- [Device classifications](https://alexandria.firecrawl.dev/agents/providers/fda-gov/devices/device_classifications): Look up FDA's medical device product classification database through openFDA: product code, device name, device class (1, 2, 3, U unclassified, N not classified, F HDE), 21 CFR regulation number and definition, medical specialty and review panel, the premarket path the code needs (510(k), PMA, 510(k) exempt or Contact ODE), and implant, life-sustaining, GMP-exempt, third-party review and summary malfunction reporting flags.
- [Device udi](https://alexandria.firecrawl.dev/agents/providers/fda-gov/devices/device_udi): Look up devices in FDA's Global Unique Device Identification Database (GUDID) through openFDA by device identifier (DI) or full GS1 UDI, brand, company, model or product code: primary DI and the other identifiers with packaging, brand, version or model, catalog number, company and DUNS, description, commercial distribution status, product codes with class and regulation, premarket submissions (510(k) or PMA numbers), and Rx/OTC, kit, combination product, single use, sterility, MRI safety and latex labelling. A GS1 UDI's lot, serial, expiry and manufacturing date come back as production_identifiers. Newest published first. GMDN terms are not returned: GMDN content is licensed by The GMDN Agency and is not public domain.
- [Pma approvals](https://alexandria.firecrawl.dev/agents/providers/fda-gov/devices/pma_approvals): Search FDA's premarket approval (PMA) database through openFDA: originals and supplements with PMA and supplement number, applicant, trade and generic name, product code, device class, advisory committee, supplement type and reason, dates received and decided, decision code and the approval order statement. Newest decision first.
- [Device events](https://alexandria.firecrawl.dev/agents/providers/fda-gov/adverse-events/device_events): Search MAUDE, FDA's database of medical device reports (adverse events and malfunctions), through openFDA. One row per report: MDR report key and number, dates received and of the event, event type (death, injury, malfunction, other), report source, the devices involved (brand, generic name, manufacturer, model, lot, product code, device class, UDI-DI), product and patient problems, patient outcomes, remedial actions, the event description and the manufacturer narrative. Newest received first. With count_by it returns counts instead of reports: by event type, product problem, patient problem, manufacturer, brand name, product code or month received. Names, addresses and phone numbers of reporters and contacts are left out.
- [First generics](https://alexandria.firecrawl.dev/agents/providers/fda-gov/approvals/first_generics): List CDER's first generic drug approvals for one calendar year (2016 on), from FDA's First Generic Drug Approvals page for that year: ANDA number, generic name, ANDA applicant, brand (reference) product with its application number where FDA links it, approval date and indication. Newest approval first.
- [Novel drug approvals](https://alexandria.firecrawl.dev/agents/providers/fda-gov/approvals/novel_drug_approvals): List CDER's novel drug approvals (new molecular entities and new therapeutic biologics) for one calendar year, from FDA's yearly Novel Drug Approvals page: drug and active ingredient, approval date, the FDA-approved use on that date, FDA's running number, the Drug Trials Snapshot link when posted, and the application number where FDA links it. Newest approval first.
- [Paragraph iv certifications](https://alexandria.firecrawl.dev/agents/providers/fda-gov/patent-challenges/paragraph_iv_certifications): Search FDA's Paragraph IV patent certifications list: per reference listed drug and strength, the date FDA received the first substantially complete ANDA with a Paragraph IV certification, how many ANDAs, 180-day exclusivity status (eligible, extinguished, deferred, non_forfeiture), decision posting, first applicant approval and first commercial marketing dates, and when the last qualifying patent expires. Read from the current workbook FDA links from its patent certifications page; newest submission first.
- [Substances](https://alexandria.firecrawl.dev/agents/providers/fda-gov/substances/substances): Look up FDA's substance registry (UNIIs from the Global Substance Registration System) through openFDA by UNII, name or code: display name, substance class, definition level, molecular formula, weight, SMILES and stereochemistry for chemicals, every name with its type (official, systematic, brand, common, code), codes in other systems (CAS, WHO-ATC, MeSH, RxNorm RXCUI, NCI Thesaurus, PubChem and others) and related substances such as active moieties, salts and metabolites.

## 1. Choose this provider when

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

US FDA drug, food and device enforcement recalls, Drugs@FDA applications and approval documents (letters, labels, reviews), complete response letters, orphan drug designations and approvals with exclusivity dates, Orange Book products with therapeutic equivalence codes, patents and exclusivities, the Purple Book of licensed biologics with reference product exclusivity and biosimilar and interchangeable status, the Paragraph IV patent certifications list, novel drug and first generic approvals, approved cell and gene therapies, structured labeling, device 510(k) decisions, PMA approvals and supplements, device classifications, GUDID device identifiers, MAUDE device and FAERS drug adverse-event reports, the UNII substance registry, the NDC directory, drug shortages, and warning letters, via openFDA, fda.gov, accessdata.fda.gov and the Purple Book.

## 2. Minimal request

Call `POST https://api.firecrawl.dev/v2/scrape` with `{ alexandria: { provider, capability, options } }`. For a batch, send `{ alexandria: [...] }` with up to 10 calls.

```json
{
  "provider": "fda-gov",
  "capability": "records/complete_response_letter",
  "options": {
    "application_number": "BLA 761303",
    "letter_date": "2024-03-22",
    "submission": "Original 2"
  }
}
```

## 3. Add provider options

Use only the options needed for the task:

- `application_number` (string, required): NDA or BLA number, e.g. NDA218705, BLA 761303 or 761303. An application with no published CRL is not_found. Pattern: ^ *([Nn][Dd][Aa]|[Bb][Ll][Aa]?)? *[0-9]{6} *$. Example: `<application_number>`
- `letter_date` (string): Letter date, YYYY-MM-DD; omit for the most recent letter. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<letter_date>`
- `submission` (string): Only needed when an application has two letters on one day, e.g. Original 1 or Original 2 for BLA761303 on 2024-03-22. Example: `<submission>`

## 4. Request through your preferred interface

### JavaScript

```javascript
const result = await firecrawl.scrape({
  alexandria: {
    provider: "fda-gov",
    capability: "records/complete_response_letter",
    options: {
      application_number: "BLA 761303",
      letter_date: "2024-03-22",
      submission: "Original 2",
    },
  },
});
```

### Python

```python
result = firecrawl.scrape_alexandria({
  "provider": "fda-gov",
  "capability": "records/complete_response_letter",
  "options": {
    "application_number": "BLA 761303",
    "letter_date": "2024-03-22",
    "submission": "Original 2"
  }
})
```

### cURL

```sh
curl https://api.firecrawl.dev/v2/scrape \
  -H "Authorization: Bearer $FIRECRAWL_API_KEY" \
  -H "Content-Type: application/json" \
  -d '{
  "alexandria": {
    "provider": "fda-gov",
    "capability": "records/complete_response_letter",
    "options": {
      "application_number": "BLA 761303",
      "letter_date": "2024-03-22",
      "submission": "Original 2"
    }
  }
}'
```

### CLI

```sh
firecrawl scrape 'fda-gov/records/complete_response_letter' \
  --options '{"application_number":"BLA 761303","letter_date":"2024-03-22","submission":"Original 2"}'
```


### MCP

Call the FCX MCP retrieve tool with this object:

```json
{
  "provider": "fda-gov",
  "capability": "records/complete_response_letter",
  "options": {
    "application_number": "BLA 761303",
    "letter_date": "2024-03-22",
    "submission": "Original 2"
  }
}
```

Ask for only the returned fields needed by the task.

## 5. Full request shape

```json
{
  "provider": "fda-gov",
  "capability": "records/complete_response_letter",
  "options": {
    "application_number": "BLA 761303",
    "letter_date": "2024-03-22",
    "submission": "Original 2"
  }
}
```

## 6. Response data

The response includes `success`, `provider`, `capability`, `creditsCost` and `data`. This example shows the provider payload in `data`:

```json
{
  "application_numbers": [
    "BLA761303"
  ],
  "application_status": "unapproved",
  "company_name": "Regeneron Pharmaceuticals, Inc.",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "fda_center": null,
  "fda_offices": [],
  "last_updated": "2026-08-13",
  "letter_date": "2024-03-22",
  "letter_type": "COMPLETE RESPONSE",
  "observed_at_ms": 1793380063190,
  "other_letters": [
    {
      "application_status": "unapproved",
      "letter_date": "2025-07-30",
      "letter_type": "COMPLETE RESPONSE",
      "submissions": []
    },
    {
      "application_status": "unapproved",
      "letter_date": "2024-03-22",
      "letter_type": "COMPLETE RESPONSE",
      "submissions": [
        "Original 1"
      ]
    }
  ],
  "pdf_url": "https://download.open.fda.gov/crl/CRL_BLA761303Original2_20240322.pdf",
  "section_headings": [
    "CLINICAL",
    "PRESCRIBING INFORMATION",
    "CARTON AND CONTAINER LABELING",
    "MEDICATION GUIDE",
    "PROPRIETARY NAME",
    "SAFETY UPDATE",
    "ADDITIONAL COMMENTS",
    "PRODUCT QUALITY",
    "OTHER"
  ],
  "signed_by": null,
  "signed_by_title": null,
  "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761303*+OR+application_number%3ABL%5C+761303*%29+AND+letter_date%3A%5B20240322+TO+20240322%5D&limit=10",
  "submissions": [
    "Original 2"
  ],
  "text": "ADMINISTRATION\n\no FN U.S. FOOD & DRUG\n&\n\nBLA 761303/Original 2\nCOMPLETE RESPONSE\n\nRegeneron Pharmaceuticals, Inc.\nAttention: Hsiao-Chi Lo, PhD\nDirector, Regulatory Affairs\n\n777 Old Saw Mill River Road\nTarrytown, NY 10591-6707\n\nDear Dr. Lo:\n\nPlease refer to your biologics license application (BLA) oe\n\n(b) (4)\n\nfor (odronextamab).\n\nWe have administratively designated your application as follows:\n\n(0) (4)\n\nThe subject of this Complete Response letter is for BLA 761303/Original 2.\n\nWe have completed our review of this application, as amended, and have determined\nthat we cannot approve this application in its present form. We have described our\nreasons for this action below and, where possible, our recommendations to address\nthese issues.\n\nCLINICAL\n\n(1) The Agency has determined that a confirmatory trial is required to be underway\nfor odronextamab for large B-cell lymphoma (LBCL) prior to approval.’ However,\na confirmatory trial in LBCL with odronextamab is not considered to be\nunderway. oe , you had enrolled |) patients in the dose-finding\nportion of OLYMPIA-3, and a patients have been enrolled in the confirmatory\nportion of the trial. Additionally, the current conduct of OLYMPIA-3 and projected\n\n1 Federal Food, Drug, and Cosmetic Act (FD&C Act) sections 506(c)(2)(A)(i) and (D)\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 2\n\ncompletion date do not provide sufficient assurance of timely completion of the\nrial.\n\nTo support resubmission of the BLA, you must address this deficiency. After\nenrollment and analysis of Part 1 (dose-finding) is completed, we recommend\nhat you request a meeting with the Agency to discuss trial benchmarks (e.g.,\nenrollment goals, site activation, proportion of primary endpoint events accrued,\nrial completion date) to allow measurement of the progress of the trial. You\nshould demonstrate in your submission that your milestones are appropriate and\nhat, prior to approval, you will demonstrate sufficient progress in the conduct of\nhe confirmatory portion of the confirmatory trial to provide sufficient assurance of\nimely completion of the trial.\n\nPRESCRIBING INFORMATION\n\nWe reserve comment on the proposed labeling until the application is otherwise\nadequate. We encourage you to review the labeling review resources on the\nPrescription Drug Labeling Resources? and Pregnancy and Lactation Labeling Final\nRule? websites, including regulations and related guidance documents and the Selected\nRequirements for Prescribing Information (SRPI) - a checklist of important format items\nfrom labeling regulations and guidances.\n\nIf you revise labeling, use the SRPI checklist to ensure that the Prescribing Information\nconforms with format items in regulations and guidances. Your response must include\nupdated content of labeling [21 CFR 601.14(b)] in structured product labeling (SPL)\nformat as described at FDA.gov.4\n\nCARTON AND CONTAINER LABELING\n\nWe reserve comment on the proposed labeling until the application is otherwise\nadequate.\n\nMEDICATION GUIDE\n\nWe reserve comment on the proposed Medication Guide until the application is\notherwise adequate.\n\nPROPRIETARY NAME\n\nPlease refer to correspondence dated, , which addresses the\nproposed proprietary name, —_. This name was found conditionally acceptable\npending approval of the application in the current review cycle. Please resubmit the\n\n(b) (4)\n\n2 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources\n\n3 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs-\nfinal-rule\n\n4 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 3\n\nproposed proprietary name when you respond to all of the application deficiencies that\nhave been identified in this letter.\n\nSAFETY UPDATE\n\nWhen you respond to the above deficiencies, include a safety update as described at\n21 CFR 601.2. The safety update should include data from all nonclinical and clinical\nstudies/trials of the product under consideration regardless of indication, dosage form,\nor dose level.\n\n(1) Describe in detail any significant changes or findings in the safety profile.\n\n(2) When assembling the sections describing discontinuations due to adverse\nevents, serious adverse events, and common adverse events, incorporate new\nsafety data as follows:\n\ne Present new safety data from the studies/clinical trials for the proposed\nindication using the same format as in the original submission.\n\ne Present tabulations of the new safety data combined with the original\napplication data.\n\ne Include tables that compare frequencies of adverse events in the original\napplication with the retabulated frequencies described in the bullet above.\n\ne For indications other than the proposed indication, provide separate tables for\nthe frequencies of adverse events occurring in Clinical trials.\n\n(3) Present a retabulation of the reasons for premature trial discontinuation by\nincorporating the drop-outs from the newly completed trials. Describe any new\ntrends or patterns identified.\n\n(4) Provide case report forms and narrative summaries for each subject who died\nduring a Clinical trial or who did not complete a trial because of an adverse event.\nIn addition, provide narrative summaries for serious adverse events.\n\n(5) Describe any information that suggests a substantial change in the incidence of\ncommon, but less serious, adverse events between the new data and the original\napplication data.\n\n(6) Provide updated exposure information for the clinical studies/trials (e.g., number\nof subjects, person time).\n\n(7) Provide a summary of worldwide experience on the safety of this product. Include\nan updated estimate of use for product marketed in other countries.\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 4\n\n(8) Provide English translations of current approved foreign labeling not previously\nsubmitted.\n\nADDITIONAL COMMENTS\nWe have the following comments/recommendations that are not approvability issues:\n\nPRODUCT QUALITY\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 5\n\nOTHER\n\nWithin one year after the date of this letter, you are required to resubmit or take other\nactions available under 21 CFR 601.3(b)). If you do not take one of these actions, we\nmay consider your lack of response a request to withdraw the application under\n\n21 CFR 601.3(c). You may also request an extension of time in which to resubmit the\napplication.\n\nA resubmission must fully address all the deficiencies listed in this letter and should be\nclearly marked with \"RESUBMISSION\" in large font, bolded type at the beginning of the\ncover letter of the submission. The cover letter should clearly state that you consider\nthis resubmission a complete response to the deficiencies outlined in this letter. A partial\nresponse to this letter will not be processed as a resubmission and will not start a new\nreview cycle.\n\nYou may request a meeting or teleconference with us to discuss what steps you need to\ntake before the application may be approved. If you wish to have such a meeting,\nsubmit your meeting request as described in the draft guidance for industry Formal\nMeetings Between the FDA and Sponsors or Applicants of PDUFA Products.\n\nThe product may not be legally marketed until you have been notified in writing that this\napplication is approved.\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255,\n\nBLA 761303/Original 2\nPage 6\n\nou ae ee,\n\nSincerely,\n\n{See appended electronic signature page}\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nSignature Page 1 of 1\n\nThis is a representation of an electronic record that was signed\nelectronically. Following this are manifestations of any and all\nelectronic signatures for this electronic record.\n\n(b) (4)\n\n03/22/2024 05:50:10 PM\n\nReference ID: 5352255",
  "text_available": true
}
```

## API reference-derived contract

The following capability contract is generated from the same normalized Alexandria API reference exposed in the API spec.

### Complete response letter

- Capability: `records/complete_response_letter`
- Description: Read one FDA complete response letter in full from openFDA: the fields complete_response_letters returns plus the letter's OCR text and a list of the application's other published CRLs. Without letter_date it returns the application's most recent letter.
- Instructions: Read the deficiencies FDA cited and the steps it asked for in a CRL, after complete_response_letters or straight from an NDA or BLA number.
- Cost: 5 credits per call
- Capability file: [Complete response letter](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/complete_response_letter)

Accepted options:
- `application_number` (string, required): NDA or BLA number, e.g. NDA218705, BLA 761303 or 761303. An application with no published CRL is not_found. Pattern: ^ *([Nn][Dd][Aa]|[Bb][Ll][Aa]?)? *[0-9]{6} *$. Example: `<application_number>`
- `letter_date` (string): Letter date, YYYY-MM-DD; omit for the most recent letter. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<letter_date>`
- `submission` (string): Only needed when an application has two letters on one day, e.g. Original 1 or Original 2 for BLA761303 on 2024-03-22. Example: `<submission>`

Response schema example:
```json
{
  "application_numbers": [
    "BLA761303"
  ],
  "application_status": "unapproved",
  "company_name": "Regeneron Pharmaceuticals, Inc.",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "fda_center": null,
  "fda_offices": [],
  "last_updated": "2026-08-13",
  "letter_date": "2024-03-22",
  "letter_type": "COMPLETE RESPONSE",
  "observed_at_ms": 1793380063190,
  "other_letters": [
    {
      "application_status": "unapproved",
      "letter_date": "2025-07-30",
      "letter_type": "COMPLETE RESPONSE",
      "submissions": []
    },
    {
      "application_status": "unapproved",
      "letter_date": "2024-03-22",
      "letter_type": "COMPLETE RESPONSE",
      "submissions": [
        "Original 1"
      ]
    }
  ],
  "pdf_url": "https://download.open.fda.gov/crl/CRL_BLA761303Original2_20240322.pdf",
  "section_headings": [
    "CLINICAL",
    "PRESCRIBING INFORMATION",
    "CARTON AND CONTAINER LABELING",
    "MEDICATION GUIDE",
    "PROPRIETARY NAME",
    "SAFETY UPDATE",
    "ADDITIONAL COMMENTS",
    "PRODUCT QUALITY",
    "OTHER"
  ],
  "signed_by": null,
  "signed_by_title": null,
  "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761303*+OR+application_number%3ABL%5C+761303*%29+AND+letter_date%3A%5B20240322+TO+20240322%5D&limit=10",
  "submissions": [
    "Original 2"
  ],
  "text": "ADMINISTRATION\n\no FN U.S. FOOD & DRUG\n&\n\nBLA 761303/Original 2\nCOMPLETE RESPONSE\n\nRegeneron Pharmaceuticals, Inc.\nAttention: Hsiao-Chi Lo, PhD\nDirector, Regulatory Affairs\n\n777 Old Saw Mill River Road\nTarrytown, NY 10591-6707\n\nDear Dr. Lo:\n\nPlease refer to your biologics license application (BLA) oe\n\n(b) (4)\n\nfor (odronextamab).\n\nWe have administratively designated your application as follows:\n\n(0) (4)\n\nThe subject of this Complete Response letter is for BLA 761303/Original 2.\n\nWe have completed our review of this application, as amended, and have determined\nthat we cannot approve this application in its present form. We have described our\nreasons for this action below and, where possible, our recommendations to address\nthese issues.\n\nCLINICAL\n\n(1) The Agency has determined that a confirmatory trial is required to be underway\nfor odronextamab for large B-cell lymphoma (LBCL) prior to approval.’ However,\na confirmatory trial in LBCL with odronextamab is not considered to be\nunderway. oe , you had enrolled |) patients in the dose-finding\nportion of OLYMPIA-3, and a patients have been enrolled in the confirmatory\nportion of the trial. Additionally, the current conduct of OLYMPIA-3 and projected\n\n1 Federal Food, Drug, and Cosmetic Act (FD&C Act) sections 506(c)(2)(A)(i) and (D)\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 2\n\ncompletion date do not provide sufficient assurance of timely completion of the\nrial.\n\nTo support resubmission of the BLA, you must address this deficiency. After\nenrollment and analysis of Part 1 (dose-finding) is completed, we recommend\nhat you request a meeting with the Agency to discuss trial benchmarks (e.g.,\nenrollment goals, site activation, proportion of primary endpoint events accrued,\nrial completion date) to allow measurement of the progress of the trial. You\nshould demonstrate in your submission that your milestones are appropriate and\nhat, prior to approval, you will demonstrate sufficient progress in the conduct of\nhe confirmatory portion of the confirmatory trial to provide sufficient assurance of\nimely completion of the trial.\n\nPRESCRIBING INFORMATION\n\nWe reserve comment on the proposed labeling until the application is otherwise\nadequate. We encourage you to review the labeling review resources on the\nPrescription Drug Labeling Resources? and Pregnancy and Lactation Labeling Final\nRule? websites, including regulations and related guidance documents and the Selected\nRequirements for Prescribing Information (SRPI) - a checklist of important format items\nfrom labeling regulations and guidances.\n\nIf you revise labeling, use the SRPI checklist to ensure that the Prescribing Information\nconforms with format items in regulations and guidances. Your response must include\nupdated content of labeling [21 CFR 601.14(b)] in structured product labeling (SPL)\nformat as described at FDA.gov.4\n\nCARTON AND CONTAINER LABELING\n\nWe reserve comment on the proposed labeling until the application is otherwise\nadequate.\n\nMEDICATION GUIDE\n\nWe reserve comment on the proposed Medication Guide until the application is\notherwise adequate.\n\nPROPRIETARY NAME\n\nPlease refer to correspondence dated, , which addresses the\nproposed proprietary name, —_. This name was found conditionally acceptable\npending approval of the application in the current review cycle. Please resubmit the\n\n(b) (4)\n\n2 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources\n\n3 https://www.fda.gov/drugs/labeling-information-drug-products/pregnancy-and-lactation-labeling-drugs-\nfinal-rule\n\n4 http://www.fda.gov/Forlndustry/DataStandards/StructuredProductLabeling/default.htm\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 3\n\nproposed proprietary name when you respond to all of the application deficiencies that\nhave been identified in this letter.\n\nSAFETY UPDATE\n\nWhen you respond to the above deficiencies, include a safety update as described at\n21 CFR 601.2. The safety update should include data from all nonclinical and clinical\nstudies/trials of the product under consideration regardless of indication, dosage form,\nor dose level.\n\n(1) Describe in detail any significant changes or findings in the safety profile.\n\n(2) When assembling the sections describing discontinuations due to adverse\nevents, serious adverse events, and common adverse events, incorporate new\nsafety data as follows:\n\ne Present new safety data from the studies/clinical trials for the proposed\nindication using the same format as in the original submission.\n\ne Present tabulations of the new safety data combined with the original\napplication data.\n\ne Include tables that compare frequencies of adverse events in the original\napplication with the retabulated frequencies described in the bullet above.\n\ne For indications other than the proposed indication, provide separate tables for\nthe frequencies of adverse events occurring in Clinical trials.\n\n(3) Present a retabulation of the reasons for premature trial discontinuation by\nincorporating the drop-outs from the newly completed trials. Describe any new\ntrends or patterns identified.\n\n(4) Provide case report forms and narrative summaries for each subject who died\nduring a Clinical trial or who did not complete a trial because of an adverse event.\nIn addition, provide narrative summaries for serious adverse events.\n\n(5) Describe any information that suggests a substantial change in the incidence of\ncommon, but less serious, adverse events between the new data and the original\napplication data.\n\n(6) Provide updated exposure information for the clinical studies/trials (e.g., number\nof subjects, person time).\n\n(7) Provide a summary of worldwide experience on the safety of this product. Include\nan updated estimate of use for product marketed in other countries.\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 4\n\n(8) Provide English translations of current approved foreign labeling not previously\nsubmitted.\n\nADDITIONAL COMMENTS\nWe have the following comments/recommendations that are not approvability issues:\n\nPRODUCT QUALITY\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nBLA 761303/Original 2\nPage 5\n\nOTHER\n\nWithin one year after the date of this letter, you are required to resubmit or take other\nactions available under 21 CFR 601.3(b)). If you do not take one of these actions, we\nmay consider your lack of response a request to withdraw the application under\n\n21 CFR 601.3(c). You may also request an extension of time in which to resubmit the\napplication.\n\nA resubmission must fully address all the deficiencies listed in this letter and should be\nclearly marked with \"RESUBMISSION\" in large font, bolded type at the beginning of the\ncover letter of the submission. The cover letter should clearly state that you consider\nthis resubmission a complete response to the deficiencies outlined in this letter. A partial\nresponse to this letter will not be processed as a resubmission and will not start a new\nreview cycle.\n\nYou may request a meeting or teleconference with us to discuss what steps you need to\ntake before the application may be approved. If you wish to have such a meeting,\nsubmit your meeting request as described in the draft guidance for industry Formal\nMeetings Between the FDA and Sponsors or Applicants of PDUFA Products.\n\nThe product may not be legally marketed until you have been notified in writing that this\napplication is approved.\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255,\n\nBLA 761303/Original 2\nPage 6\n\nou ae ee,\n\nSincerely,\n\n{See appended electronic signature page}\n\nU.S. Food and Drug Administration\nSilver Spring, MD 20993\nwww.fda.gov\n\nReference ID: 5352255\n\nSignature Page 1 of 1\n\nThis is a representation of an electronic record that was signed\nelectronically. Following this are manifestations of any and all\nelectronic signatures for this electronic record.\n\n(b) (4)\n\n03/22/2024 05:50:10 PM\n\nReference ID: 5352255",
  "text_available": true
}
```

### Complete response letters

- Capability: `records/complete_response_letters`
- Description: Search FDA complete response letters (CRLs), the letters FDA sends when it will not approve an NDA or BLA as submitted, as published in openFDA. Filter by letter date range, words in the letter, company, application number and whether the application was later approved; newest first. Each letter has its date, type, company, application numbers, review office and signatory, the letter's own section headings, a short excerpt and the PDF link. FDA publishes CRLs in batches, so last_updated is the dataset date and a letter a sponsor has announced may not be published yet.
- Instructions: Find CRLs issued in a time window, to a company, for an application or citing a deficiency such as "Form 483" or immunogenicity. Read a letter in full with complete_response_letter; join to drug_applications and drug_application_documents through application_numbers.
- Cost: 5 credits per call
- Capability file: [Complete response letters](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/complete_response_letters)

Accepted options:
- `application_number` (string): NDA or BLA number, e.g. NDA218705, BLA 761303 or 761303. Pattern: ^ *([Nn][Dd][Aa]|[Bb][Ll][Aa]?)? *[0-9]{6} *$. Example: `<application_number>`
- `application_status` (string): approved: FDA has since approved the application; unapproved: it has not. Example: `approved`
- `company_name` (string): Company name words, e.g. Regeneron. Example: `<company_name>`
- `letter_date_from` (string): Earliest letter date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<letter_date_from>`
- `letter_date_to` (string): Latest letter date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<letter_date_to>`
- `limit` (number): limit Example: `10`
- `query` (string): Words that must all appear in the letter text; wrap a phrase in double quotes, e.g. "Form 483" or immunogenicity. Example: `<query>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-08-13",
  "letters": [
    {
      "application_numbers": [
        "BLA761303"
      ],
      "application_status": "unapproved",
      "company_name": "Regeneron Pharmaceuticals, Inc.",
      "excerpt": "…FACILITY INSPECTIONS (1) Following a CGMP inspection of oe , listed in this application, FDA conveyed deficiencies to the representative of the facility. The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response. The facility's satisfactory responses are dependent on…",
      "fda_center": "CDER",
      "fda_offices": [],
      "letter_date": "2025-07-30",
      "letter_type": "COMPLETE RESPONSE",
      "pdf_url": "https://download.open.fda.gov/crl/CRL_BLA761303_20250730.pdf",
      "section_headings": [
        "FACILITY INSPECTIONS",
        "PRESCRIBING INFORMATION",
        "CARTON AND CONTAINER LABELING",
        "MEDICATION GUIDE",
        "PROPRIETARY NAME",
        "SAFETY UPDATE",
        "OTHER"
      ],
      "signed_by": null,
      "signed_by_title": null,
      "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761303*+OR+application_number%3ABL%5C+761303*%29+AND+letter_date%3A%5B20250730+TO+20250730%5D&limit=10",
      "submissions": [],
      "text_available": true
    },
    {
      "application_numbers": [
        "BLA761400"
      ],
      "application_status": "approved",
      "company_name": "Regeneron Pharmaceuticals, Inc.",
      "excerpt": "…FACILITY INSPECTIONS 1. During a recent inspection of O@ (FEI: ©) listed in this application, FDA conveyed deficiencies to the representative of the facility. The facility should provide satisfactory responses to these deficiencies to the FDA office indicated on the FDA 483 prior to your complete response to your application. Your complete response should…",
      "fda_center": "CDER",
      "fda_offices": [
        "Office of Oncologic Diseases",
        "Office of New Drugs"
      ],
      "letter_date": "2024-08-20",
      "letter_type": "COMPLETE RESPONSE",
      "pdf_url": "https://download.open.fda.gov/crl/CRL_BLA761400_20240820.pdf",
      "section_headings": [
        "FACILITY INSPECTIONS",
        "PRESCRIBING INFORMATION",
        "CARTON AND CONTAINER LABELING",
        "PROPRIETARY NAME",
        "RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS",
        "SAFETY UPDATE",
        "ADDITIONAL COMMENTS",
        "OTHER"
      ],
      "signed_by": "Marc Theoret, MD",
      "signed_by_title": "Supervisory Associate Director (Acting)",
      "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761400*+OR+application_number%3ABL%5C+761400*%29+AND+letter_date%3A%5B20240820+TO+20240820%5D&limit=10",
      "submissions": [],
      "text_available": true
    },
    {
      "application_numbers": [
        "BLA761303"
      ],
      "application_status": "unapproved",
      "company_name": "Regeneron Pharmaceuticals, Inc.",
      "excerpt": "…CLINICAL (1) The Agency has determined that a confirmatory trial is required to be underway for odronextamab for follicular lymphoma prior to approval.! However, a confirmatory trial in follicular lymphoma with odronextamab is not considered to be underway. , you had enrolled @ patients in the safety run-in portion o' -1, @ patients in the dose-finding…",
      "fda_center": null,
      "fda_offices": [],
      "letter_date": "2024-03-22",
      "letter_type": "COMPLETE RESPONSE",
      "pdf_url": "https://download.open.fda.gov/crl/CRL_BLA761303Original1_20240322.pdf",
      "section_headings": [
        "CLINICAL",
        "PRESCRIBING INFORMATION",
        "CARTON AND CONTAINER LABELING",
        "MEDICATION GUIDE",
        "PROPRIETARY NAME",
        "SAFETY UPDATE",
        "ADDITIONAL COMMENTS",
        "PRODUCT QUALITY",
        "OTHER"
      ],
      "signed_by": null,
      "signed_by_title": null,
      "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761303*+OR+application_number%3ABL%5C+761303*%29+AND+letter_date%3A%5B20240322+TO+20240322%5D&limit=10",
      "submissions": [
        "Original 1"
      ],
      "text_available": true
    },
    {
      "application_numbers": [
        "BLA761303"
      ],
      "application_status": "unapproved",
      "company_name": "Regeneron Pharmaceuticals, Inc.",
      "excerpt": "…CLINICAL (1) The Agency has determined that a confirmatory trial is required to be underway for odronextamab for large B-cell lymphoma (LBCL) prior to approval.’ However, a confirmatory trial in LBCL with odronextamab is not considered to be underway. oe , you had enrolled |) patients in the dose-finding portion of OLYMPIA-3, and a patients have been…",
      "fda_center": null,
      "fda_offices": [],
      "letter_date": "2024-03-22",
      "letter_type": "COMPLETE RESPONSE",
      "pdf_url": "https://download.open.fda.gov/crl/CRL_BLA761303Original2_20240322.pdf",
      "section_headings": [
        "CLINICAL",
        "PRESCRIBING INFORMATION",
        "CARTON AND CONTAINER LABELING",
        "MEDICATION GUIDE",
        "PROPRIETARY NAME",
        "SAFETY UPDATE",
        "ADDITIONAL COMMENTS",
        "PRODUCT QUALITY",
        "OTHER"
      ],
      "signed_by": null,
      "signed_by_title": null,
      "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761303*+OR+application_number%3ABL%5C+761303*%29+AND+letter_date%3A%5B20240322+TO+20240322%5D&limit=10",
      "submissions": [
        "Original 2"
      ],
      "text_available": true
    },
    {
      "application_numbers": [
        "BLA761355"
      ],
      "application_status": "approved",
      "company_name": "Regeneron Pharmaceuticals, Inc.",
      "excerpt": "…PROPRIETARY NAME Please refer to correspondence dated, March 27, 2023, which addresses the proposed proprietary name, Eylea HD. This name was found acceptable pending approval of the application in the current review cycle. Please resubmit the proposed proprietary name when you respond to the application deficiency. SAFETY UPDATE When you respond to the…",
      "fda_center": "CDER",
      "fda_offices": [
        "Division of Ophthalmology",
        "Office of Specialty Medicine"
      ],
      "letter_date": "2023-06-27",
      "letter_type": "COMPLETE RESPONSE",
      "pdf_url": "https://download.open.fda.gov/crl/761355_2024_Orig1s000OtherActionLtrs.pdf",
      "section_headings": [
        "PROPRIETARY NAME",
        "SAFETY UPDATE",
        "ADDITIONAL COMMENTS"
      ],
      "signed_by": "Wiley A. Chambers, MD",
      "signed_by_title": "Director",
      "source_url": "https://api.fda.gov/transparency/crl.json?search=%28application_number%3ABLA%5C+761355*+OR+application_number%3ABL%5C+761355*%29+AND+letter_date%3A%5B20230627+TO+20230627%5D&limit=10",
      "submissions": [],
      "text_available": true
    }
  ],
  "next_skip": null,
  "observed_at_ms": 1793380055038,
  "pagination_truncated": false,
  "skip": 0,
  "source_url": "https://api.fda.gov/transparency/crl.json?search=company_name%3A%22Regeneron%22&sort=letter_date%3Adesc&skip=0&limit=10",
  "total_matching": 5
}
```

### Device clearances

- Capability: `records/device_clearances`
- Description: Search device 510(k) submission decision records and resolve a k_number. Preserve decision_code and decision_date; do not equate every returned submission with clearance or PMA approval.
- Instructions: Search device 510(k) submission decision records and resolve a k_number. Preserve decision_code and decision_date; do not equate every returned submission with clearance or PMA approval.
- Cost: 5 credits per call
- Capability file: [Device clearances](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/device_clearances)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "device_clearances",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-07",
  "next_skip": 1,
  "observed_at_ms": 1789509514341,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "address_1": "9705 International Ct. N.",
        "address_2": "",
        "advisory_committee": "",
        "advisory_committee_description": "Unknown",
        "applicant": "Bioderm, Inc.",
        "city": "St. Petersburg",
        "clearance_type": "Traditional",
        "contact": "MARIE B TEIXEIRA",
        "country_code": "US",
        "date_received": "1998-08-21",
        "decision_code": "SESE",
        "decision_date": "1998-10-13",
        "decision_description": "Substantially Equivalent",
        "device_name": "BTF THIN FILM WOUND DRESSING",
        "expedited_review_flag": "",
        "k_number": "K982939",
        "openfda": {
          "device_class": "U",
          "device_name": "Dressing, Wound And Burn, Occlusive",
          "fei_number": [
            "3014562978",
            "3005012805",
            "3041276591",
            "1000305720",
            "1000117748",
            "3031168520",
            "3010419931",
            "3012421607",
            "3002807111",
            "3004365956",
            "3005747797",
            "3010034780",
            "3030733800",
            "3010041511",
            "3002806830",
            "1219313",
            "3003636207",
            "1526534",
            "3012494290",
            "3012502601",
            "3013557562",
            "3001451571"
          ],
          "medical_specialty_description": "Unknown",
          "registration_number": [
            "3014562978",
            "3005012805",
            "3041276591",
            "3031168520",
            "1320894",
            "3010419931",
            "3012421607",
            "9680091",
            "3004365956",
            "3010034780",
            "3011137372",
            "3030733800",
            "3010041511",
            "3005941719",
            "1219313",
            "3003636207",
            "1526534",
            "3012494290",
            "1223925",
            "1644312",
            "3012502601",
            "3013557562"
          ],
          "regulation_number": ""
        },
        "postal_code": "33716",
        "product_code": "MGP",
        "review_advisory_committee": "SU",
        "state": "FL",
        "statement_or_summary": "Summary",
        "third_party_flag": "N",
        "zip_code": "33716"
      },
      "record_id": "K982939",
      "source_url": "https://api.fda.gov/device/510k.json?search=k_number%3A%22K982939%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/device/510k.json?skip=0&limit=1",
  "total_matching": 176070
}
```

### Device recalls

- Capability: `records/device_recalls`
- Description: Search medical device enforcement recall records and resolve a recall_number. Preserve recall reason, status and classification; this is not the separate device recall classification dataset.
- Instructions: Search medical device enforcement recall records and resolve a recall_number. Preserve recall reason, status and classification; this is not the separate device recall classification dataset.
- Cost: 5 credits per call
- Capability file: [Device recalls](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/device_recalls)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "device_recalls",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-09",
  "next_skip": 1,
  "observed_at_ms": 1789509514341,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "address_1": "15 Hampshire St",
        "address_2": "",
        "center_classification_date": "20230811",
        "city": "Mansfield",
        "classification": "Class I",
        "code_info": "GTIN: 20884521128009  LOT Numbers: 2200400154",
        "country": "United States",
        "distribution_pattern": "US Nationwide - Worldwide Distribution  Foreign:  Argentina Austria Bahrain Bangladesh Belgium Brazil Brunei Darussalam Canada Cayman Islands China Costa Rica Czech Republic Denmark Dominican Republic Finland France French Polynesia Germany Greece Hungary India Iran, Islamic Republic Of Ireland Italy Kuwait Malaysia Maldives Mauritius Mexico Nepal Netherlands New Caledonia Nicaragua Norway Philippines Poland Portugal Puerto Rico Saudi Arabia Singapore Slovakia South Africa Spain Sri Lanka Sweden Switzerland Thailand Turkey United Arab Emirates United Kingdom",
        "event_id": "92660",
        "initial_firm_notification": "Letter",
        "more_code_info": "",
        "openfda": {},
        "postal_code": "02048-1113",
        "product_description": "MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray    REF: 8888102004HP",
        "product_quantity": "685 units",
        "product_type": "Devices",
        "reason_for_recall": "Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to  full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus",
        "recall_initiation_date": "20230628",
        "recall_number": "Z-2372-2023",
        "recalling_firm": "Covidien LP",
        "report_date": "20230823",
        "state": "MA",
        "status": "Ongoing",
        "voluntary_mandated": "Voluntary: Firm initiated"
      },
      "record_id": "Z-2372-2023",
      "source_url": "https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2372-2023%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/device/enforcement.json?skip=0&limit=1",
  "total_matching": 39949
}
```

### Drug application documents

- Capability: `records/drug_application_documents`
- Description: Drugs@FDA documents for one NDA, ANDA or BLA: approval and action letters, labels, reviews, summary reviews, medication guides and other documents with type, date and URL, newest first, each with its submission (type, number, status, status date, class). Read from openFDA's Drugs@FDA dataset, whose documents match the Drugs@FDA application page. A document's presence is not proof that the product is currently approved or marketed.
- Instructions: Find an application's approval letters, labels or FDA reviews and their dates, e.g. the original approval letter or the latest label PDF. Use the application_number from orange_book or drug_applications.
- Cost: 5 credits per call
- Capability file: [Drug application documents](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_application_documents)

Accepted options:
- `application_number` (string, required): Drugs@FDA application, e.g. NDA020702, ANDA076477 or BLA761069. No match is not_found. Pattern: ^(NDA|ANDA|BLA)[0-9]{6}$. Example: `<application_number>`

Response schema example:
```json
{
  "application_number": "NDA020702",
  "brand_names": [
    "LIPITOR"
  ],
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "documents": [
    {
      "date": "2024-04-03",
      "document_id": "78041",
      "submission_class": "Labeling",
      "submission_number": "81",
      "submission_status": "AP",
      "submission_status_date": "2024-04-02",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Letter",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020702Orig1s081ltr.pdf"
    },
    {
      "date": "2024-04-03",
      "document_id": "78046",
      "submission_class": "Labeling",
      "submission_number": "81",
      "submission_status": "AP",
      "submission_status_date": "2024-04-02",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Label",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020702s081lbl.pdf"
    },
    {
      "date": "2022-12-15",
      "document_id": "72893",
      "submission_class": "Labeling",
      "submission_number": "79",
      "submission_status": "AP",
      "submission_status_date": "2022-12-07",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Letter",
      "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020702Orig1s079correctedltr.pdf"
    },
    {
      "date": "2022-12-09",
      "document_id": "72831",
      "submission_class": "Labeling",
      "submission_number": "79",
      "submission_status": "AP",
      "submission_status_date": "2022-12-07",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Label",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020702Orig1s079correctedlbl.pdf"
    },
    {
      "date": "2020-11-18",
      "document_id": "65260",
      "submission_class": "Labeling",
      "submission_number": "77",
      "submission_status": "AP",
      "submission_status_date": "2020-11-16",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Letter",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020702Orig1s077ltr.pdf"
    },
    {
      "date": "2020-11-16",
      "document_id": "65234",
      "submission_class": "Labeling",
      "submission_number": "77",
      "submission_status": "AP",
      "submission_status_date": "2020-11-16",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Label",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s077lbl.pdf"
    },
    {
      "date": "2020-09-29",
      "document_id": "64723",
      "submission_class": "Labeling",
      "submission_number": "78",
      "submission_status": "AP",
      "submission_status_date": "2020-09-25",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Label",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020702s078lbl.pdf"
    },
    {
      "date": "2020-09-28",
      "document_id": "64699",
      "submission_class": "Labeling",
      "submission_number": "78",
      "submission_status": "AP",
      "submission_status_date": "2020-09-25",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Letter",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020702Orig1s078ltr.pdf"
    },
    {
      "date": "2019-11-29",
      "document_id": "61091",
      "submission_class": "Labeling",
      "submission_number": "74",
      "submission_status": "AP",
      "submission_status_date": "2019-11-27",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Letter",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020702Orig1s074ltr.pdf"
    },
    {
      "date": "2019-11-29",
      "document_id": "61105",
      "submission_class": "Labeling",
      "submission_number": "74",
      "submission_status": "AP",
      "submission_status_date": "2019-11-27",
      "submission_type": "SUPPL",
      "title": null,
      "type": "Label",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020702s074lbl.pdf"
    },
    {
      "date": "2010-03-16",
      "document_id": "20841",
      "submission_class": "Type 1 - New Molecular Entity",
      "submission_number": "1",
      "submission_status": "AP",
      "submission_status_date": "1996-12-17",
      "submission_type": "ORIG",
      "title": null,
      "type": "Review",
      "url": "http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020702_s000.pdf"
    }
  ],
  "documents_total": 90,
  "drugs_at_fda_url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020702",
  "last_updated": "2026-10-16",
  "observed_at_ms": 1792445912391,
  "source_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22NDA020702%22&limit=1",
  "sponsor_name": "UPJOHN"
}
```

### Drug applications

- Capability: `records/drug_applications`
- Description: Search Drugs@FDA applications and submission histories, or resolve an application_number. Inspect submission statuses: a returned record alone is not proof of current approval or availability.
- Instructions: Search Drugs@FDA applications and submission histories, or resolve an application_number. Inspect submission statuses: a returned record alone is not proof of current approval or availability.
- Cost: 5 credits per call
- Capability file: [Drug applications](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_applications)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "drug_applications",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-15",
  "next_skip": 1,
  "observed_at_ms": 1789509514341,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "application_number": "ANDA088119",
        "products": [
          {
            "active_ingredients": [
              {
                "name": "ISONIAZID",
                "strength": "300MG"
              }
            ],
            "brand_name": "ISONIAZID",
            "dosage_form": "TABLET",
            "marketing_status": "Discontinued",
            "product_number": "001",
            "reference_drug": "No",
            "reference_standard": "No",
            "route": "ORAL"
          }
        ],
        "sponsor_name": "DURAMED PHARMS BARR",
        "submissions": [
          {
            "submission_class_code": "LABELING",
            "submission_class_code_description": "Labeling",
            "submission_number": "15",
            "submission_status": "AP",
            "submission_status_date": "19970512",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "LABELING",
            "submission_class_code_description": "Labeling",
            "submission_number": "13",
            "submission_status": "AP",
            "submission_status_date": "19891115",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "MANUF (CMC)",
            "submission_class_code_description": "Manufacturing (CMC)",
            "submission_number": "5",
            "submission_status": "AP",
            "submission_status_date": "19850619",
            "submission_type": "SUPPL"
          },
          {
            "submission_number": "1",
            "submission_status": "AP",
            "submission_status_date": "19830317",
            "submission_type": "ORIG"
          },
          {
            "submission_class_code": "LABELING",
            "submission_class_code_description": "Labeling",
            "submission_number": "11",
            "submission_status": "AP",
            "submission_status_date": "19890817",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "MANUF (CMC)",
            "submission_class_code_description": "Manufacturing (CMC)",
            "submission_number": "3",
            "submission_status": "AP",
            "submission_status_date": "19850529",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "MANUF (CMC)",
            "submission_class_code_description": "Manufacturing (CMC)",
            "submission_number": "1",
            "submission_status": "AP",
            "submission_status_date": "19830805",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "MANUF (CMC)",
            "submission_class_code_description": "Manufacturing (CMC)",
            "submission_number": "8",
            "submission_status": "AP",
            "submission_status_date": "19850619",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "LABELING",
            "submission_class_code_description": "Labeling",
            "submission_number": "14",
            "submission_status": "AP",
            "submission_status_date": "19901109",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "MANUF (CMC)",
            "submission_class_code_description": "Manufacturing (CMC)",
            "submission_number": "6",
            "submission_status": "AP",
            "submission_status_date": "19850619",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "LABELING",
            "submission_class_code_description": "Labeling",
            "submission_number": "12",
            "submission_status": "AP",
            "submission_status_date": "19890321",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "MANUF (CMC)",
            "submission_class_code_description": "Manufacturing (CMC)",
            "submission_number": "4",
            "submission_status": "AP",
            "submission_status_date": "19850529",
            "submission_type": "SUPPL"
          },
          {
            "submission_class_code": "LABELING",
            "submission_class_code_description": "Labeling",
            "submission_number": "10",
            "submission_status": "AP",
            "submission_status_date": "19880331",
            "submission_type": "SUPPL"
          }
        ]
      },
      "record_id": "ANDA088119",
      "source_url": "https://api.fda.gov/drug/drugsfda.json?search=application_number%3A%22ANDA088119%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/drug/drugsfda.json?skip=0&limit=1",
  "total_matching": 29329
}
```

### Drug events

- Capability: `records/drug_events`
- Description: FAERS drug adverse event reports: patient reactions, suspect and concomitant drugs, seriousness and reporter qualification. Search e.g. patient.drug.medicinalproduct:aspirin, patient.reaction.reactionmeddrapt:nausea or receivedate:[20250101 TO 20251231], or resolve a safetyreportid using record_id. A report is not evidence that the drug caused the reaction; FAERS lags the calendar by months.
- Instructions: FAERS drug adverse event reports: patient reactions, suspect and concomitant drugs, seriousness and reporter qualification. Search e.g. patient.drug.medicinalproduct:aspirin, patient.reaction.reactionmeddrapt:nausea or receivedate:[20250101 TO 20251231], or resolve a safetyreportid using record_id. A report is not evidence that the drug caused the reaction; FAERS lags the calendar by months.
- Cost: 5 credits per call
- Capability file: [Drug events](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_events)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "drug_events",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-07-30",
  "next_skip": 1,
  "observed_at_ms": 1790553970151,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "companynumb": "JACAN16471",
        "fulfillexpeditecriteria": "1",
        "patient": {
          "drug": [
            {
              "drugadministrationroute": "041",
              "drugauthorizationnumb": "019813",
              "drugcharacterization": "1",
              "drugindication": "DRUG ABUSE",
              "medicinalproduct": "DURAGESIC-100"
            }
          ],
          "patientdeath": {
            "patientdeathdate": null,
            "patientdeathdateformat": null
          },
          "patientonsetage": "26",
          "patientonsetageunit": "801",
          "patientsex": "1",
          "reaction": [
            {
              "reactionmeddrapt": "DRUG ADMINISTRATION ERROR"
            },
            {
              "reactionmeddrapt": "OVERDOSE"
            }
          ]
        },
        "primarysource": {
          "qualification": "3",
          "reportercountry": "CANADA"
        },
        "receiptdate": "20080625",
        "receiptdateformat": "102",
        "receivedate": "20080707",
        "receivedateformat": "102",
        "receiver": null,
        "safetyreportid": "5801206-7",
        "sender": {
          "senderorganization": "FDA-Public Use"
        },
        "serious": "1",
        "seriousnessdeath": "1",
        "transmissiondate": "20090109",
        "transmissiondateformat": "102"
      },
      "record_id": "5801206-7",
      "source_url": "https://api.fda.gov/drug/event.json?search=safetyreportid%3A%225801206-7%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/drug/event.json?skip=0&limit=1",
  "total_matching": 20692690
}
```

### Drug labels

- Capability: `records/drug_labels`
- Description: Search structured drug labeling and resolve a source label id. Includes source warnings and indications where available. Label presence does not itself establish FDA approval.
- Instructions: Search structured drug labeling and resolve a source label id. Includes source warnings and indications where available. Label presence does not itself establish FDA approval.
- Cost: 5 credits per call
- Capability file: [Drug labels](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_labels)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "drug_labels",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-15",
  "next_skip": 1,
  "observed_at_ms": 1789509514341,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "active_ingredient": [
          "ACTIVE INGREDIENT SILICEA HPUS 2X and higher"
        ],
        "do_not_use": [
          "Do not use if capseal is broken or missing. Close the cap tightly after use."
        ],
        "dosage_and_administration": [
          "DOSAGE Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose."
        ],
        "effective_time": "20210902",
        "id": "ca7bbcc8-2354-375c-e053-2995a90a72a0",
        "inactive_ingredient": [
          "INACTIVE INGREDIENTS Sucrose"
        ],
        "indications_and_usage": [
          "INDICATIONS Condition listed above or as directed by the physician"
        ],
        "keep_out_of_reach_of_children": [
          "Keep this and all medication out of reach of children"
        ],
        "openfda": {
          "brand_name": [
            "SILICEA"
          ],
          "generic_name": [
            "SILICEA"
          ],
          "is_original_packager": [
            true
          ],
          "manufacturer_name": [
            "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc"
          ],
          "package_ndc": [
            "15631-0404-0",
            "15631-0404-1",
            "15631-0404-2",
            "15631-0404-3",
            "15631-0404-4",
            "15631-0404-5",
            "15631-0404-6",
            "15631-0404-7"
          ],
          "product_ndc": [
            "15631-0404"
          ],
          "product_type": [
            "HUMAN OTC DRUG"
          ],
          "route": [
            "ORAL"
          ],
          "spl_id": [
            "ca7bbcc8-2354-375c-e053-2995a90a72a0"
          ],
          "spl_set_id": [
            "0000025c-6dbf-4af7-a741-5cbacaed519a"
          ],
          "substance_name": [
            "SILICON DIOXIDE"
          ],
          "unii": [
            "ETJ7Z6XBU4"
          ],
          "upc": [
            "8907460005526"
          ]
        },
        "package_label_principal_display_panel": [
          "Mini-Label Label-Pellets Blister-Pack Carton-Pack"
        ],
        "pregnancy_or_breast_feeding": [
          "As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product."
        ],
        "purpose": [
          "USES USES: Temporary Relief - Acne, Boils* * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
        ],
        "questions": [
          "QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com Rxhomeo, Inc 3200 Commander Dr, Ste 100-W1, Carrollton, TX 75006 USA"
        ],
        "set_id": "0000025c-6dbf-4af7-a741-5cbacaed519a",
        "spl_product_data_elements": [
          "SILICEA SILICEA SUCROSE SILICON DIOXIDE SILICON DIOXIDE"
        ],
        "stop_use": [
          "If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional."
        ],
        "storage_and_handling": [
          "STORAGE Store in a cool dark place"
        ],
        "version": "2",
        "warnings": [
          "WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional. As with any drug, if you are pregnant, or nursing a baby, seek professional advice before taking this product. Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use."
        ]
      },
      "record_id": "ca7bbcc8-2354-375c-e053-2995a90a72a0",
      "source_url": "https://api.fda.gov/drug/label.json?search=id%3A%22ca7bbcc8-2354-375c-e053-2995a90a72a0%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/drug/label.json?skip=0&limit=1",
  "total_matching": 262883
}
```

### Drug ndc

- Capability: `records/drug_ndc`
- Description: NDC Directory product listings: product NDC, brand and generic names, labeler, dosage form, route, active ingredients, marketing category and packages. Search e.g. brand_name:Lipitor, generic_name:atorvastatin or labeler_name:Pfizer, or resolve a product_ndc using record_id. A listing is not proof of FDA approval.
- Instructions: NDC Directory product listings: product NDC, brand and generic names, labeler, dosage form, route, active ingredients, marketing category and packages. Search e.g. brand_name:Lipitor, generic_name:atorvastatin or labeler_name:Pfizer, or resolve a product_ndc using record_id. A listing is not proof of FDA approval.
- Cost: 5 credits per call
- Capability file: [Drug ndc](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_ndc)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "drug_ndc",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-25",
  "next_skip": 1,
  "observed_at_ms": 1790553970428,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "active_ingredients": [
          {
            "name": "ALCOHOL",
            "strength": "67 mL/100mL"
          }
        ],
        "application_number": "505G(a)(3)",
        "brand_name": "Antiseptic Gel Handwash",
        "brand_name_base": "Antiseptic Gel Handwash",
        "dosage_form": "LIQUID",
        "finished": true,
        "generic_name": "Antiseptic Gel Handwash",
        "labeler_name": "SafeSpace Co.",
        "listing_expiration_date": "20261231",
        "marketing_category": "OTC MONOGRAPH DRUG",
        "marketing_start_date": "20200130",
        "openfda": {
          "is_original_packager": [
            true
          ],
          "manufacturer_name": [
            "SafeSpace Co."
          ],
          "spl_set_id": [
            "bd969c73-af6c-6bb3-e053-2995a90a6a3f"
          ],
          "unii": [
            "3K9958V90M"
          ],
          "upc": [
            "0857783001096"
          ]
        },
        "packaging": [
          {
            "description": "118 mL in 1 BOTTLE, PLASTIC (81471-693-01)",
            "marketing_start_date": "20200130",
            "package_ndc": "81471-693-01",
            "sample": false
          }
        ],
        "product_id": "81471-693_28c54937-a2fb-a331-e063-6294a90a81b3",
        "product_ndc": "81471-693",
        "product_type": "HUMAN OTC DRUG",
        "route": [
          "TOPICAL"
        ],
        "spl_id": "28c54937-a2fb-a331-e063-6294a90a81b3"
      },
      "record_id": "81471-693",
      "source_url": "https://api.fda.gov/drug/ndc.json?search=product_ndc%3A%2281471-693%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/drug/ndc.json?skip=0&limit=1",
  "total_matching": 138259
}
```

### Drug recalls

- Capability: `records/drug_recalls`
- Description: Search drug enforcement recall records, including classification, reason and recall status. Search product_description, recalling_firm or report_date, or resolve a recall_number using record_id.
- Instructions: Search drug enforcement recall records, including classification, reason and recall status. Search product_description, recalling_firm or report_date, or resolve a recall_number using record_id.
- Cost: 5 credits per call
- Capability file: [Drug recalls](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_recalls)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "drug_recalls",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-09",
  "next_skip": 1,
  "observed_at_ms": 1789509514341,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "address_1": "4625 N University St",
        "address_2": "N/A",
        "center_classification_date": "20151117",
        "city": "Peoria",
        "classification": "Class II",
        "code_info": "Lot #: 072915, Exp 10/29/2015",
        "country": "United States",
        "distribution_pattern": "Nationwide",
        "event_id": "72241",
        "initial_firm_notification": "Letter",
        "openfda": {},
        "postal_code": "61614-5828",
        "product_description": "Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.",
        "product_quantity": "1 vial",
        "product_type": "Drugs",
        "reason_for_recall": "Lack of Assurance of Sterility:  A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.",
        "recall_initiation_date": "20150903",
        "recall_number": "D-321-2016",
        "recalling_firm": "Kalman Health & Wellness, Inc. dba Essential Wellness Pharma",
        "report_date": "20151125",
        "state": "IL",
        "status": "Terminated",
        "termination_date": "20171229",
        "voluntary_mandated": "Voluntary: Firm initiated"
      },
      "record_id": "D-321-2016",
      "source_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-321-2016%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/drug/enforcement.json?skip=0&limit=1",
  "total_matching": 17965
}
```

### Drug shortages

- Capability: `records/drug_shortages`
- Description: FDA drug shortage entries: generic name, company, presentation, status (Current, Resolved, To Be Discontinued), therapeutic category and posting and update dates. Search e.g. generic_name:amoxicillin, status:Current or company_name:Pfizer, or resolve a package_ndc using record_id; one package NDC can appear in more than one entry.
- Instructions: FDA drug shortage entries: generic name, company, presentation, status (Current, Resolved, To Be Discontinued), therapeutic category and posting and update dates. Search e.g. generic_name:amoxicillin, status:Current or company_name:Pfizer, or resolve a package_ndc using record_id; one package NDC can appear in more than one entry.
- Cost: 5 credits per call
- Capability file: [Drug shortages](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/drug_shortages)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "drug_shortages",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-26",
  "next_skip": 1,
  "observed_at_ms": 1790553970698,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "company_name": "Pfizer Inc.",
        "contact_info": "844-646-4398",
        "discontinued_date": "02/25/2026",
        "dosage_form": "Capsule",
        "generic_name": "Clindamycin Hydrochloride Capsule",
        "initial_posting_date": "02/25/2026",
        "package_ndc": "0009-0225-02",
        "presentation": "Cleocin Hydrochloride, Capsule, 150 mg (NDC 0009-0225-02)",
        "related_info": "Discontinuation of the manufacture of the drug",
        "status": "To Be Discontinued",
        "therapeutic_category": [
          "Anti-Infective"
        ],
        "update_date": "02/25/2026",
        "update_type": "New"
      },
      "record_id": "0009-0225-02",
      "source_url": "https://api.fda.gov/drug/shortages.json?search=package_ndc%3A%220009-0225-02%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/drug/shortages.json?skip=0&limit=1",
  "total_matching": 1601
}
```

### Food recalls

- Capability: `records/food_recalls`
- Description: Search food enforcement recall records and resolve a recall_number. Source recall status and affected product descriptions are preserved.
- Instructions: Search food enforcement recall records and resolve a recall_number. Source recall status and affected product descriptions are preserved.
- Cost: 5 credits per call
- Capability file: [Food recalls](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/food_recalls)

Accepted options:
- `limit` (number): limit Example: `5`
- `query` (string): Plain openFDA search expression, e.g. product_description:aspirin or report_date:[20250101 TO 20251231]. Use spaces around AND, OR and TO; do not URL-encode the expression or use + as a space. Literal plus signs are preserved. Mutually exclusive with record_id. Omit both to browse source default order. Example: `<query>`
- `record_id` (string): Source identifier returned by this dataset. Exact quoted lookup; mutually exclusive with query. Pattern: ^[A-Za-z0-9-]{1,100}$. Example: `<record_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "dataset": "food_recalls",
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-09",
  "next_skip": 1,
  "observed_at_ms": 1789509514341,
  "pagination_truncated": false,
  "records": [
    {
      "data": {
        "address_1": "4131 SW 47th Ave Ste 1403",
        "address_2": "",
        "center_classification_date": "20161025",
        "city": "Davie",
        "classification": "Class II",
        "code_info": "UPC No. 632687615989; Lot No. 30661601, Exp. Date 05/2018.",
        "country": "United States",
        "distribution_pattern": "FL, MI, MS, and OH.",
        "event_id": "75272",
        "initial_firm_notification": "Letter",
        "more_code_info": "",
        "openfda": {},
        "postal_code": "33314-4036",
        "product_description": "CytoDetox, Hydrolyzed Clinoptilolite Fragments, 1 oz./30 mL, OTC Non-Sterile.  Dietary supplement.",
        "product_quantity": "1,990 bottles",
        "product_type": "Food",
        "reason_for_recall": "Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.",
        "recall_initiation_date": "20160808",
        "recall_number": "F-0276-2017",
        "recalling_firm": "Pharmatech LLC",
        "report_date": "20161102",
        "state": "FL",
        "status": "Terminated",
        "termination_date": "20240923",
        "voluntary_mandated": "Voluntary: Firm initiated"
      },
      "record_id": "F-0276-2017",
      "source_url": "https://api.fda.gov/food/enforcement.json?search=recall_number%3A%22F-0276-2017%22&skip=0&limit=1"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/food/enforcement.json?skip=0&limit=1",
  "total_matching": 29406
}
```

### Orange book

- Capability: `records/orange_book`
- Description: Orange Book products for one application, active ingredient or trade name, each with therapeutic equivalence (TE) codes, RLD and reference-standard flags, approval date, listed patents (expiry, drug substance and product flags, every patent use code, delist request) and exclusivities with expiry. Products come from openFDA's Orange Book API; patents and exclusivities come from FDA's monthly Orange Book data file, read by byte range, because openFDA keeps only one use code per patent. A listed patent is the applicant's submission, not a finding on validity or infringement.
- Instructions: Check generic equivalence ratings, patent expiries, patent use codes and exclusivities for a drug, e.g. to estimate generic entry. Search by ingredient or trade name, or pass application_number (NDA020702) for every product of one application. ANDA products carry no patents; biologics (BLA) are not in the Orange Book.
- Cost: 5 credits per call
- Capability file: [Orange book](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/orange_book)

Accepted options:
- `application_number` (string): Orange Book application, e.g. NDA020702, ANDA076477 or 020702; returns every product of that application. No match is not_found. Pattern: ^(NDA|ANDA|N|A)?[0-9]{6}$. Example: `<application_number>`
- `ingredient` (string): Active ingredient words, e.g. tirzepatide or atorvastatin calcium; matches ingredient names containing them. Pattern: ^[^"\\]+$. Example: `<ingredient>`
- `limit` (number): Products per page, ordered by application then product number. Example: `25`
- `skip` (number): skip Example: `0`
- `trade_name` (string): Proprietary name words, e.g. Lipitor. Pattern: ^[^"\\]+$. Example: `<trade_name>`

Response schema example:
```json
{
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-10-16",
  "next_skip": 2,
  "observed_at_ms": 1792445841987,
  "orange_book_file": {
    "file_name": "EOBZIP_2026_09.zip",
    "last_modified": "Tue, 13 Oct 2026 16:09:04 GMT",
    "source_url": "https://www.fda.gov/media/76860/download"
  },
  "pagination_truncated": false,
  "products": [
    {
      "applicant": "ELI LILLY AND CO",
      "applicant_full_name": "ELI LILLY AND CO",
      "application_number": "NDA215866",
      "approval_date": "2022-05-13",
      "approved_prior_to_1982": false,
      "dosage_form": "SOLUTION",
      "exclusivities": [
        {
          "code": "NCE",
          "expiration_date": "2027-05-13"
        },
        {
          "code": "NPP",
          "expiration_date": "2028-12-19"
        }
      ],
      "ingredients": [
        {
          "name": "TIRZEPATIDE",
          "strength": "2.5MG/0.5ML (2.5MG/0.5ML)"
        }
      ],
      "marketing_status": "HUMAN PRESCRIPTION DRUG",
      "orange_book_url": "https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=215866&Appl_type=N",
      "patents": [
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2041-12-30",
          "patent_number": "12295987",
          "submission_date": "2025-06-11",
          "use_codes": [
            "U-4192",
            "U-4193"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "12453755",
          "submission_date": "2025-11-17",
          "use_codes": [
            "U-4375",
            "U-4376",
            "U-4377",
            "U-4378",
            "U-4379",
            "U-4380",
            "U-4381",
            "U-4382",
            "U-4383",
            "U-4384",
            "U-4385",
            "U-4386"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": true,
          "expiration_date": "2036-05-13",
          "patent_number": "9474780",
          "submission_date": "2022-06-09",
          "use_codes": [
            "U-4374"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2039-07-22",
          "patent_number": "12343382",
          "submission_date": "2025-07-25",
          "use_codes": [
            "U-4401",
            "U-4229",
            "U-4230",
            "U-4231",
            "U-4232",
            "U-4400"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2039-07-22",
          "patent_number": "12616740",
          "submission_date": "2026-05-05",
          "use_codes": [
            "U-4500",
            "U-4501",
            "U-4502"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "12629404",
          "submission_date": "2026-06-05",
          "use_codes": [
            "U-4533",
            "U-4534"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "11357820",
          "submission_date": "2022-06-30",
          "use_codes": []
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "12453756",
          "submission_date": "2025-11-17",
          "use_codes": []
        }
      ],
      "product_number": "001",
      "reference_listed_drug": true,
      "reference_standard": true,
      "route": "SUBCUTANEOUS",
      "te_codes": [],
      "trade_name": "MOUNJARO (AUTOINJECTOR)"
    },
    {
      "applicant": "ELI LILLY AND CO",
      "applicant_full_name": "ELI LILLY AND CO",
      "application_number": "NDA215866",
      "approval_date": "2022-05-13",
      "approved_prior_to_1982": false,
      "dosage_form": "SOLUTION",
      "exclusivities": [
        {
          "code": "NCE",
          "expiration_date": "2027-05-13"
        },
        {
          "code": "NPP",
          "expiration_date": "2028-12-19"
        }
      ],
      "ingredients": [
        {
          "name": "TIRZEPATIDE",
          "strength": "5MG/0.5ML (5MG/0.5ML)"
        }
      ],
      "marketing_status": "HUMAN PRESCRIPTION DRUG",
      "orange_book_url": "https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=002&Appl_No=215866&Appl_type=N",
      "patents": [
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2041-12-30",
          "patent_number": "12295987",
          "submission_date": "2025-06-11",
          "use_codes": [
            "U-4193",
            "U-4192"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "12453755",
          "submission_date": "2025-11-17",
          "use_codes": [
            "U-4376",
            "U-4383",
            "U-4379",
            "U-4375",
            "U-4380",
            "U-4382",
            "U-4377",
            "U-4381",
            "U-4384",
            "U-4385",
            "U-4386",
            "U-4378"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": true,
          "expiration_date": "2036-05-13",
          "patent_number": "9474780",
          "submission_date": "2022-06-09",
          "use_codes": [
            "U-4374"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2039-07-22",
          "patent_number": "12343382",
          "submission_date": "2025-07-25",
          "use_codes": [
            "U-4229",
            "U-4230",
            "U-4231",
            "U-4232",
            "U-4401",
            "U-4400"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": false,
          "drug_substance": false,
          "expiration_date": "2039-07-22",
          "patent_number": "12616740",
          "submission_date": "2026-05-05",
          "use_codes": [
            "U-4500",
            "U-4501",
            "U-4502"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "12629404",
          "submission_date": "2026-06-05",
          "use_codes": [
            "U-4533",
            "U-4534"
          ]
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "11357820",
          "submission_date": "2022-06-30",
          "use_codes": []
        },
        {
          "delist_requested": false,
          "drug_product": true,
          "drug_substance": false,
          "expiration_date": "2039-06-14",
          "patent_number": "12453756",
          "submission_date": "2025-11-17",
          "use_codes": []
        }
      ],
      "product_number": "002",
      "reference_listed_drug": true,
      "reference_standard": true,
      "route": "SUBCUTANEOUS",
      "te_codes": [],
      "trade_name": "MOUNJARO (AUTOINJECTOR)"
    }
  ],
  "skip": 0,
  "source_url": "https://api.fda.gov/drug/orangebook.json?search=products.application_number%3A%22215866%22+AND+products.application_type%3A%22N%22&sort=products.application_number%3Aasc%2Cproduct_number%3Aasc&skip=0&limit=2",
  "total_matching": 24
}
```

### Orphan designation

- Capability: `records/orphan_designation`
- Description: Read one FDA orphan drug designation by its OOPD key or a pasted OOPD detail-page URL, with the fields orphan_designations returns: designation and date, sponsor and country, status, withdrawal date and every orphan approval with approved indication and exclusivity end date.
- Instructions: Get a clean record for a pasted OOPD page (detailedIndex.cfm?cfgridkey=...) or re-read a designation found with orphan_designations.
- Cost: 5 credits per call
- Capability file: [Orphan designation](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/orphan_designation)

Accepted options:
- `designation_id` (string, required): OOPD key (cfgridkey), e.g. 825421, or the detail-page URL https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=825421. An unknown key is not_found. Pattern: ^ *([0-9]{1,9}|https?://(www\.)?accessdata\.fda\.gov/scripts/opdlisting/oopd/detailed[Ii]ndex\.cfm\?.*) *$. Example: `<designation_id>`

Response schema example:
```json
{
  "approvals": [
    {
      "approval_date": "2021-05-28",
      "approved_indication": "Treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. (Indication withdrawn 5/16/2024)",
      "exclusivity_end_date": "2023-08-04",
      "exclusivity_protected_indication": null,
      "generic_name": "infigratinib",
      "trade_name": "Truseltiq"
    }
  ],
  "designation": "Treatment of cholangiocarcinoma",
  "designation_date": "2019-09-11",
  "designation_id": "707019",
  "generic_name": "infigratinib",
  "observed_at_ms": 1793379826083,
  "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=707019",
  "sponsor": "QED Therapeutics, Inc.",
  "sponsor_country": "United States",
  "status": "withdrawn_or_revoked",
  "trade_name": "Truseltiq",
  "withdrawn_or_revoked_date": "2023-08-04"
}
```

### Orphan designations

- Capability: `records/orphan_designations`
- Description: Search FDA orphan drug designations and orphan approvals in the Office of Orphan Products Development database by product (generic or trade name), sponsor, designated disease or condition, designation dates, approval dates and status. Each designation has its text and date, sponsor and country, status, withdrawal date and every orphan approval with approved indication, exclusivity end date and exclusivity-protected indication. Newest designation first, or newest approval first when filtered by approval dates; with approval dates, approvals lists only those in the window.
- Instructions: Find orphan designations for a disease or drug, a sponsor's orphan programs, orphan approvals in a time window, or when a drug's orphan exclusivity ends. Words match at word starts, so ALS does not match metals.
- Cost: 5 credits per call
- Capability file: [Orphan designations](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/orphan_designations)

Accepted options:
- `approved_from` (string): Earliest orphan approval date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<approved_from>`
- `approved_to` (string): Latest orphan approval date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<approved_to>`
- `designated_from` (string): Earliest designation date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<designated_from>`
- `designated_to` (string): Latest designation date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<designated_to>`
- `designation` (string): Disease or condition words in the designation, e.g. amyotrophic lateral sclerosis or Duchenne. Example: `<designation>`
- `limit` (number): limit Example: `25`
- `product` (string): Generic or trade name words, e.g. pembrolizumab or Keytruda. Example: `<product>`
- `skip` (number): skip Example: `0`
- `sponsor` (string): Sponsor name words, e.g. Vertex. Example: `<sponsor>`
- `status` (string): designated: no orphan approval yet; approved: approved for the orphan indication; withdrawn_or_revoked: designation withdrawn or revoked. Combine with product, sponsor, designation or a date. Example: `designated`

Response schema example:
```json
{
  "designations": [
    {
      "approvals": [],
      "designation": "treatment of amyotrophic lateral sclerosis",
      "designation_date": "2025-10-17",
      "designation_id": "1100225",
      "generic_name": "allogeneic, cord blood-derived T regulatory cells that express neurotrophic homing markers",
      "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1100225",
      "sponsor": "Cellenkos Inc",
      "sponsor_country": "United States",
      "status": "designated",
      "trade_name": null,
      "withdrawn_or_revoked_date": null
    },
    {
      "approvals": [],
      "designation": "treatment of amyotrophic lateral sclerosis (ALS)",
      "designation_date": "2025-08-07",
      "designation_id": "1088925",
      "generic_name": "unasnemab",
      "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1088925",
      "sponsor": "Tanabe Pharma America Inc.",
      "sponsor_country": "United States",
      "status": "designated",
      "trade_name": null,
      "withdrawn_or_revoked_date": null
    },
    {
      "approvals": [],
      "designation": "treatment of amyotrophic lateral sclerosis",
      "designation_date": "2025-08-07",
      "designation_id": "1088825",
      "generic_name": "tetramethylpyrazine nitrone",
      "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1088825",
      "sponsor": "Guangzhou Magpie Pharmaceuticals Co., Ltd.",
      "sponsor_country": "China",
      "status": "designated",
      "trade_name": null,
      "withdrawn_or_revoked_date": null
    },
    {
      "approvals": [],
      "designation": "treatment of amyotrophic lateral sclerosis",
      "designation_date": "2025-07-22",
      "designation_id": "1085925",
      "generic_name": "pegylated insulin-like growth factor I",
      "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1085925",
      "sponsor": "Sarcomed AB",
      "sponsor_country": "Sweden",
      "status": "designated",
      "trade_name": null,
      "withdrawn_or_revoked_date": null
    },
    {
      "approvals": [],
      "designation": "treatment of amyotrophic lateral sclerosis",
      "designation_date": "2025-07-03",
      "designation_id": "1083225",
      "generic_name": "myotropic adeno-associated virus (AAVMYO2) gene therapy vector containing sKL and a muscle-specific promoter",
      "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=1083225",
      "sponsor": "Klotho Neurosciences, Inc.",
      "sponsor_country": "United States",
      "status": "designated",
      "trade_name": null,
      "withdrawn_or_revoked_date": null
    }
  ],
  "next_skip": 5,
  "observed_at_ms": 1793379826034,
  "skip": 0,
  "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/",
  "total_matching": 13
}
```

### Warning letter

- Capability: `records/warning_letter`
- Description: Read one FDA warning letter, or a posted close-out or response letter, from fda.gov: company, MARCS-CMS case number, letter date, issuing office, delivery method, regulated products, the recipient and office header blocks, and the full letter text as plain paragraphs.
- Instructions: Read the violations, cited regulations and requested corrective actions in a letter found with warning_letters, or a pasted fda.gov warning letter URL.
- Cost: 5 credits per call
- Capability file: [Warning letter](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/warning_letter)

Accepted options:
- `url` (string, required): Letter page URL from warning_letters, e.g. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sca-pharmaceuticals-llc-724202-09142026. A missing page is not_found. Pattern: ^https?://(www\.)?fda\.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/[a-z0-9-]+/?([?#].*)?$. Example: `<url>`

Response schema example:
```json
{
  "company_name": "SCA Pharmaceuticals, LLC",
  "content_current_as_of": "2026-10-13",
  "delivery_method": "VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED",
  "issuing_office": "Center for Drug Evaluation and Research (CDER)",
  "letter_date": "2026-09-14",
  "letter_id": "sca-pharmaceuticals-llc-724202-09142026",
  "letter_type": "WARNING LETTER",
  "marcs_cms_number": "724202",
  "observed_at_ms": 1792445854182,
  "parties": [
    {
      "address": "8821 Knoedl Court, Little Rock, AR, 72205-4600, United States",
      "lines": [
        "Kenneth P. Bonnell",
        "Chief Quality Officer",
        "SCA Pharmaceuticals, LLC"
      ],
      "role": "Recipient"
    },
    {
      "address": "United States",
      "lines": [
        "Center for Drug Evaluation and Research (CDER)"
      ],
      "role": "Issuing Office"
    }
  ],
  "products": [
    "Drugs"
  ],
  "reference_number": null,
  "text": "WARNING LETTER\nWL # 724202\n\nSeptember 14, 2026\n\nDear Mr. Bonnell:\n\nYou registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1 on December 13, 2013, and most recently on December 5, 2025. From October 20, 2025, to October 30, 2025, an FDA investigator inspected your facility, SCA Pharmaceuticals, LLC located at 8821 Knoedl Court, Little Rock, Arkansas 72205. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.\n\nFDA issued a Form FDA 483 to your facility on October 30, 2025. We reviewed your November 21, 2025, and December 31, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Based on this inspection, it appears you produced drugs that violate the FDCA.\n\nA. Compounded Drug Products under the FDCA\n\nUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.\n\nAn outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.\n\nB. Violations of the FDCA\n\nAdulterated Drug Products\n\nThe FDA investigator collected evidence indicating that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator collected evidence indicating that:\n\n1. Your facility lacked routine and rigorous certification of the ISO 5 areas, including airflow visualization studies performed under dynamic conditions.\n\n2. Your firm did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.\n\n3. Your component control is not adequately designed or maintained to prevent contamination of product contact surfaces due to the presence of foreign (unusual) material between the stopper ribs of syringes.\n\n4. Your compounding technicians and aseptic assistants employ poor practices which introduce risk of microbial contamination into the ISO 5 classified critical areas during production of drugs intended to be sterile.\n\nFor example, during the production of Fentanyl Citrate 2 mcg/mL Bupivacaine HCl 0.125% lot #1125035913 and/or Methadone HCl 10 mg/mL lot #1125035922, your compounding technicians:\n\na. Moved quickly in a critical area or in an area immediately adjacent to a critical area such that unidirectional airflow is likely to be disrupted.\n\nb. Leaned into the hood, allowing their head and upper body to enter the ISO 5 classified critical area, thereby disrupting unidirectional airflow.\n\nc. Blocked first pass air by placing gloved hands directly over the following:\n\ni. Hanging IV bag ports when making sterile connections.\n\nii. The IV bag ports when disinfecting prior to filling.\n\niii. The open filled syringes and the syringe cap trays during the process of screwing caps onto the syringes.\n\nd. Conducted aseptic operations on or directly above the hood deck surface in vertical flow hoods, which prevents unidirectional first air with minimal turbulence from surrounding aseptic operations during sterile connections and filling of drug products intended or expected to be sterile into open sterile containers.\n\ne. Regularly rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO 5 work area.\n\nAdditionally, your aseptic assistants:\n\na. Moved quickly in an area immediately adjacent to a critical area such that unidirectional airflow is likely to be disrupted.\n\nb. Used disinfectant in a manner insufficient to achieve adequate levels of disinfection of materials, such as the IV bag ports, during transfer into the ISO 5 classified critical areas by spraying very quickly or from a significant distance or failing to treat both sides of the IV bags. Prior to disinfection, aseptic assistants regularly touched the IV bag ports in the ISO 7 area with their gloved hands.\n\n5. Your environmental monitoring program lacks adequate routine environmental monitoring that captures data representative of aseptic production conditions. For example, during the production of Fentanyl Citrate 2 mcg/mL Bupivacaine HCl 0.125% lot #1125035913:\n\na. The active air sampler is placed to the far right of the hood instead of adjacent to the areas where aseptic operations occur, including the left and center portions of the ISO 5 classified hood.\n\nb. Compounding technicians do not always carefully roll their individual fingers across the media touch plate during personnel monitoring. The compounding technician quickly touched each fingertip to the media plates instead of methodically rolling their fingertips.\n\n6. Your firm failed to perform adequate airflow visualization studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Your airflow visualization studies are deficient because:\n\na. The studies do not clearly demonstrate that the airflow pattern sweeps over and away from the critical areas near and on the ISO 5 classified LAF hood work surface where aseptic operations occur. Instead, the smoke appears to arc out of the hood significantly higher than the critical area and then travel up toward the ceiling in the surrounding ISO 7 classified area.\n\nb. In your most recent airflow visualization study VAL-25-044-FR, you indicated that (b)(4) people are allowed in ISO 7 (b)(4) Room (b)(4) during aseptic operations; however, the smoke study videos provided during the FDA inspection only include a maximum of (b)(4) people, and fail to demonstrate that airflow patterns inside the ISO 5 classified critical areas are not impacted by a large number of personnel moving inside cleanroom Room (b)(4).\n\nThe FDA investigator also collected evidence indicating CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:\n\n1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).\n\n2. Your firm failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 CFR 211.42(c)(10)(iii)).\n\n3. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).\n\n4. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).\n\n5. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)). Specifically, our review of the data collected during the inspection revealed that your firm does not maintain the production video recordings which are used to determine root causes and corrective actions during investigations. For example, after recovering microbial contamination inside the ISO 5 classified critical area during the production of Ketamine HCl 10 mg/mL lot 1125035065, your Quality Unit evaluated the production video recording as part of excursion investigation EXC-2025-0045 to examine aseptic practices for potential root causes. However, instead of retaining the video recording as a quality related document, you only retained still images. Your Chief Quality Officer stated that video recordings are kept for approximately (b)(4) before being overwritten.\n\nOutsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.\n\nUnder section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is also a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.\n\nC. Corrective Actions\n\nWe have reviewed your facility’s responses to the Form FDA 483 dated November 21, 2025, and December 31, 2025.\n\nSome of your corrective actions appear adequate. However, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:\n\n1. Although you stated that you performed airflow visualization studies in all (b)(4) hoods, you did not clearly demonstrate that these studies were performed in all (b)(4) hoods during the most recent airflow visualization assessment, performed in 2025. Additionally, while you concluded that the hoods are identical and therefore functionally equivalent, this approach does not account for potential variations in the HEPA filter performance, for example, resulting from particulate accumulation over time, nor the impact of physical placement of hoods within the room—including proximity to doors, return vents, and other environmental factors that may affect airflow where production activities are occurring.\n\nSome of your corrective actions appear deficient:\n\n1. You did not demonstrate that the probable root cause of inadequate material sanitization had no impact on the released portions of the batch associated with microbial excursions in the ISO 5 classified areas during production. You indicated both in your investigations and in your response that your material sanitization process is robust, but also concluded that the microbial contamination was most likely due to inadequate material sanitization.\n\nYou failed to demonstrate that microbial contamination was not present in the materials associated with the released portions of the batch. You did not demonstrate that the material sanitization process for the released portions of the batches did not include the same deficiencies as the material sanitization for the rejected portion of the batch. Further, you failed to initiate any corrective and preventative action plans to determine whether you need to improve your material sanitization process to prevent reoccurrence.\n\n2. It appears that your visual inspection system is inadequate because you classify particulate defects as major and therefore only characterize and investigate the observed particles when the defect rate is above the major defect threshold of (b)(4)%. Extrinsic particulates should be classified as critical, and the intrinsic particulates should be evaluated based on multiple factors, including particle size and route of administration, to determine the appropriate defect classification. Your SOP ILP-001-LR, Product Inspection and Defect Classification, states, “If a DRL (Defect Rate Limit) threshold is exceeded related to ‘Particulate/material in solution,’ the particulate/material must be identified during the event.” According to your visual inspection data, you detected between (b)(4) and (b)(4) particles in (b)(4) separate lots between April 2025 and September 2025, only (b)(4) lots of which exceeded the (b)(4)% threshold for major defects. According to your Deviation log, only (b)(4) defect incidents were investigated between April 2025 and September 2025, and these were related to any Defect Rate Limit Threshold Exceedance, not just those involving particles. Therefore, you do not have an adequate system in place to ensure that you identify and appropriately investigate contaminating particles.\n\n3. You did not commit to revising the minor defect classification for “[f]oreign (unusual) material, e.g., cardboard trapped between stopper ribs” to account for the criticality of the foreign material. While you noted that any units exhibiting this defect are rejected, the defect rate limit applied to minor defects ((b)(4)%) is not appropriate for adequately investigating, trending, and performing corrective actions, as necessary, to mitigate this contamination risk.\n\nYou did not provide adequate documentation to demonstrate that foreign materials are contained within the ribs of the syringe stoppers in non-product-contact area and will not pose contamination risks to the drug product. In addition, the syringe filling process demonstrates that the foreign material does come into contact with product-contact area of the syringes. For example, any cardboard particles trapped within the syringe ribs may be pressed against the inner syringe wall during filling, potentially introducing particles onto a surface that subsequently contacts the drug product solution.\n\nIn addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]\n\nFDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.\n\nD. Conclusion\n\nThe violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.\n\nYou should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.\n\nWithin fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.\n\nAll correspondence should refer to the Warning Letter Number above (# 724202) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.\n\nSincerely,\n/S/\n\nMatthew J. Lash\nActing Director\nOffice of Compounding Quality and Compliance\nOffice of Compliance\nCenter for Drug Evaluation and Research\n\ncc: Scott P. Luce, Chief Executive Officer\n\n____________________\n\n1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).",
  "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sca-pharmaceuticals-llc-724202-09142026"
}
```

### Warning letters

- Capability: `records/warning_letters`
- Description: Search FDA warning letters posted on fda.gov: company, letter issue and posted dates, issuing office, subject, links to any posted response or close-out letter, and a matching excerpt. Filter by full-text query (company, subject or letter text), issuing office, issue year, or letters issued or posted in the last 7, 30, 60 or 90 days. The fda.gov listing holds letters posted since January 2021; older letters are in FDA's archive and not searched.
- Instructions: Find warning letters about a company, product, ingredient or violation type, or recent letters from one FDA center. Read a letter's full text with warning_letter.
- Cost: 5 credits per call
- Capability file: [Warning letters](https://alexandria.firecrawl.dev/agents/providers/fda-gov/records/warning_letters)

Accepted options:
- `issued_within_days` (number): Letters issued in the last 7, 30, 60 or 90 days. Example: `7`
- `issuing_office` (string): Issuing office words, e.g. Center for Drug Evaluation and Research or CDER. Example: `<issuing_office>`
- `limit` (number): limit Example: `25`
- `posted_within_days` (number): Letters posted on fda.gov in the last 7, 30, 60 or 90 days. Example: `7`
- `query` (string): Full-text search over company, subject and letter text, e.g. semaglutide or "SCA Pharmaceuticals" in double quotes for a phrase. Example: `<query>`
- `skip` (number): skip Example: `0`
- `sort` (string): sort Example: `posted_desc`
- `year` (number): Letter issue year. Example: `1990`

Response schema example:
```json
{
  "letters": [
    {
      "closeout_letter": null,
      "company_name": "SCA Pharmaceuticals, LLC",
      "excerpt": "… SCA Pharmaceuticals, LLC … WARNING LETTER WL # 724202 September … 30, 2025, an FDA investigator inspected your facility, SCA Pharmaceuticals, LLC located at 8821 Knoedl Court, Little …",
      "issuing_office": "Center for Drug Evaluation and Research (CDER)",
      "letter_id": "sca-pharmaceuticals-llc-724202-09142026",
      "letter_issue_date": "2026-09-14",
      "posted_date": "2026-10-13",
      "response_letter": null,
      "subject": "CGMP/Finished Pharmaceuticals/Adulterated",
      "url": "https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sca-pharmaceuticals-llc-724202-09142026"
    }
  ],
  "next_skip": null,
  "observed_at_ms": 1792445847163,
  "pagination_truncated": false,
  "skip": 0,
  "source_url": "https://www.fda.gov/datatables/views/ajax?_drupal_ajax=1&_wrapper_format=drupal_ajax&pager_element=0&view_args=&view_base_path=inspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fwarning-letters%2Fdatatables-data&view_display_id=warning_letter_solr_block&view_name=warning_letter_solr_index&view_path=%2Finspections-compliance-enforcement-and-criminal-investigations%2Fcompliance-actions-and-activities%2Fwarning-letters&draw=1&start=0&length=5&order%5B0%5D%5Bcolumn%5D=0&order%5B0%5D%5Bdir%5D=desc&search_api_fulltext=%22SCA+Pharmaceuticals%22",
  "total_matching": 1
}
```

### Cell gene therapies

- Capability: `biologics/cell_gene_therapies`
- Description: List CBER's approved cellular and gene therapy products, the list FDA maintains, joined to the CBER BLAs in the Purple Book's monthly data file: product and trade name, proper name, manufacturer, FDA product page, first approval date, and per BLA the applicant, proprietary names, licensure, reference product and orphan exclusivity end dates. Newest approval first.
- Instructions: Which cell and gene therapies FDA has approved, when, by whom, and when their exclusivities end. A curated subset of purple_book with center CBER, which also lists vaccines, blood products and other CBER biologics.
- Cost: 5 credits per call
- Capability file: [Cell gene therapies](https://alexandria.firecrawl.dev/agents/providers/fda-gov/biologics/cell_gene_therapies)

Accepted options:
- `approved_from` (string): Earliest first approval date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<approved_from>`
- `approved_to` (string): Latest first approval date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<approved_to>`
- `limit` (number): limit Example: `25`
- `query` (string): Product, trade, proper name or manufacturer words, e.g. Zolgensma, CAR-T makers like Kite, or autotemcel. Example: `<query>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "content_current_as_of": "2026-09-17",
  "license": {
    "attribution": "Source: U.S. Food and Drug Administration (FDA), Approved Cellular and Gene Therapy Products (CBER) joined to the Purple Book monthly data file. Use does not imply FDA endorsement.",
    "name": "Public domain (U.S. Government work)",
    "url": "https://www.fda.gov/about-fda/about-website/website-policies"
  },
  "next_skip": null,
  "observed_at_ms": 1793392117048,
  "products": [
    {
      "blas": [
        {
          "applicant": "Novartis Gene Therapies, Inc.",
          "bla_number": "125694",
          "first_approval_date": "2019-05-24",
          "licensure": [
            "Licensed"
          ],
          "orphan_exclusivity_expires": [
            "2026-11-24"
          ],
          "proper_name": "onasemnogene abeparvovec-xioi",
          "proprietary_names": [
            "Zolgensma"
          ],
          "reference_product_exclusivity_expires": "2031-11-24"
        }
      ],
      "first_approval_date": "2019-05-24",
      "manufacturer": "Novartis Gene Therapies, Inc.",
      "name": "ZOLGENSMA (onasemnogene abeparvovec-xioi)",
      "product_url": "https://www.fda.gov/vaccines-blood-biologics/zolgensma",
      "proper_name": "onasemnogene abeparvovec-xioi",
      "trade_name": "ZOLGENSMA"
    }
  ],
  "purple_book_file_url": "https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv",
  "purple_book_release": "2026-10",
  "skip": 0,
  "source_url": "https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products",
  "total_matching": 1
}
```

### Purple book

- Capability: `biologics/purple_book`
- Description: Search the Purple Book, FDA's database of licensed biological products (CDER and CBER), from its latest monthly data file. One row per BLA: applicant, proper and proprietary names, license types (351(a) reference product, 351(k) biosimilar or interchangeable), the reference product a biosimilar cites, first approval date, date of first licensure, reference product, first interchangeable and orphan exclusivity end dates, whether a patent list was provided, and every licensed presentation with strength, dosage form, route, marketing status and approval dates. Newest first approval first.
- Instructions: Biologic loss of exclusivity: when a reference product's 12-year exclusivity ends, which biosimilars and interchangeables cite a reference product, or what a BLA licenses. Use orange_book for small-molecule patents and exclusivities, cell_gene_therapies for CBER's curated cell and gene therapy list, and paragraph_iv_certifications for generic patent challenges. Words match at word starts.
- Cost: 5 credits per call
- Capability file: [Purple book](https://alexandria.firecrawl.dev/agents/providers/fda-gov/biologics/purple_book)

Accepted options:
- `applicant` (string): Applicant name words, e.g. Amgen. Example: `<applicant>`
- `approved_from` (string): Earliest first approval date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<approved_from>`
- `approved_to` (string): Latest first approval date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<approved_to>`
- `bla_number` (string): BLA number, e.g. 125057 or BLA 125057. Example: `<bla_number>`
- `center` (string): center Example: `CDER`
- `license_type` (string): 351(a): reference products and other stand-alone BLAs; 351(k): biosimilars, or those also found interchangeable. Example: `351(a)`
- `limit` (number): limit Example: `10`
- `name` (string): Proper or proprietary name words, e.g. adalimumab or Humira. Example: `<name>`
- `reference_product` (string): Reference product name words: biosimilars and interchangeables citing it, e.g. Stelara. Example: `<reference_product>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "biologics": [
    {
      "applicant": "AbbVie Inc.",
      "bla_number": "125057",
      "center": "CDER",
      "date_notes": [],
      "date_of_first_licensure": null,
      "first_approval_date": "2002-12-31",
      "first_interchangeable_exclusivity_expires": [],
      "license_number": "1889",
      "license_types": [
        "351(a)"
      ],
      "orphan_exclusivity_expires": [
        "2028-02-24"
      ],
      "patent_list_provided": true,
      "products": [
        {
          "approval_date": "2002-12-31",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Autoinjector",
          "product_number": "001",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "40MG/0.8ML",
          "submission_type": "Original",
          "supplement_number": null
        },
        {
          "approval_date": "2002-12-31",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Pre-Filled Syringe",
          "product_number": "002",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "40MG/0.8ML",
          "submission_type": "Original",
          "supplement_number": null
        },
        {
          "approval_date": "2008-02-21",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Disc*",
          "presentation": "Pre-Filled Syringe",
          "product_number": "003",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "20MG/0.4ML",
          "submission_type": "Supplement",
          "supplement_number": "114"
        },
        {
          "approval_date": "2013-04-24",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Disc*",
          "presentation": "Single-Dose Vial",
          "product_number": "004",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "40MG/0.8ML",
          "submission_type": "Supplement",
          "supplement_number": "322"
        },
        {
          "approval_date": "2014-09-23",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Disc*",
          "presentation": "Pre-Filled Syringe",
          "product_number": "005",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "10MG/0.2ML",
          "submission_type": "Supplement",
          "supplement_number": "356"
        },
        {
          "approval_date": "2015-11-23",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Pre-Filled Syringe",
          "product_number": "006",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "40MG/0.4ML",
          "submission_type": "Supplement",
          "supplement_number": "394"
        },
        {
          "approval_date": "2016-03-09",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Autoinjector",
          "product_number": "007",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "40MG/0.4ML",
          "submission_type": "Supplement",
          "supplement_number": "398"
        },
        {
          "approval_date": "2016-10-17",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Pre-Filled Syringe",
          "product_number": "008",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "80MG/0.8ML",
          "submission_type": "Supplement",
          "supplement_number": "400"
        },
        {
          "approval_date": "2017-04-21",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Autoinjector",
          "product_number": "009",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "80MG/0.8ML",
          "submission_type": "Supplement",
          "supplement_number": "401"
        },
        {
          "approval_date": "2017-04-28",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Pre-Filled Syringe",
          "product_number": "010",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "20MG/0.2ML",
          "submission_type": "Supplement",
          "supplement_number": "402"
        },
        {
          "approval_date": "2017-04-28",
          "dosage_form": "Injection",
          "interchangeable_approval_date": null,
          "license_type": "351(a)",
          "licensure": "Licensed",
          "marketing_status": "Rx",
          "presentation": "Pre-Filled Syringe",
          "product_number": "011",
          "proprietary_name": "Humira",
          "release_change": null,
          "route": "Subcutaneous",
          "strength": "10MG/0.1ML",
          "submission_type": "Supplement",
          "supplement_number": "402"
        }
      ],
      "proper_name": "adalimumab",
      "proprietary_names": [
        "Humira"
      ],
      "reference_product": null,
      "reference_product_exclusivity_expires": null
    }
  ],
  "file_release": "2026-10",
  "file_url": "https://www.accessdata.fda.gov/drugsatfda_docs/PurpleBook/2026/purplebook-search-October-data-download.csv",
  "license": {
    "attribution": "Source: U.S. Food and Drug Administration (FDA), Purple Book: Database of Licensed Biological Products (monthly data file). Use does not imply FDA endorsement.",
    "name": "Public domain (U.S. Government work)",
    "url": "https://www.fda.gov/about-fda/about-website/website-policies"
  },
  "next_skip": null,
  "observed_at_ms": 1793392115622,
  "skip": 0,
  "source_url": "https://purplebooksearch.fda.gov/downloads",
  "total_matching": 1
}
```

### Device classifications

- Capability: `devices/device_classifications`
- Description: Look up FDA's medical device product classification database through openFDA: product code, device name, device class (1, 2, 3, U unclassified, N not classified, F HDE), 21 CFR regulation number and definition, medical specialty and review panel, the premarket path the code needs (510(k), PMA, 510(k) exempt or Contact ODE), and implant, life-sustaining, GMP-exempt, third-party review and summary malfunction reporting flags.
- Instructions: What a product code means and how it is regulated, which product codes a regulation covers, or the class III codes for a device type. Product codes join device_events, device_clearances, pma_approvals and device_udi.
- Cost: 5 credits per call
- Capability file: [Device classifications](https://alexandria.firecrawl.dev/agents/providers/fda-gov/devices/device_classifications)

Accepted options:
- `device` (string): Device name words, matched as a phrase, e.g. glucose monitor. Example: `<device>`
- `device_class` (string): device_class Example: `1`
- `limit` (number): limit Example: `25`
- `product_code` (string): Three-letter FDA product code, e.g. QBJ. Pattern: ^ *[A-Za-z]{3} *$. Example: `<product_code>`
- `regulation_number` (string): 21 CFR regulation number, e.g. 862.1355. Pattern: ^ *[0-9]{3}\.[0-9]{1,4} *$. Example: `<regulation_number>`
- `skip` (number): skip Example: `0`
- `specialty` (string): Medical specialty words, e.g. Clinical Chemistry or Cardiovascular. Example: `<specialty>`

Response schema example:
```json
{
  "classifications": [
    {
      "definition": "An integrated continuous glucose monitoring system (iCGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.",
      "device_class": "2",
      "device_name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated",
      "gmp_exempt": false,
      "implant": false,
      "life_sustaining": false,
      "medical_specialty": "Clinical Chemistry",
      "product_code": "QBJ",
      "regulation_number": "862.1355",
      "review_panel": "CH",
      "source_url": "https://api.fda.gov/device/classification.json?search=product_code%3AQBJ&limit=1",
      "submission_type": "510(k)",
      "summary_malfunction_reporting": "Ineligible",
      "third_party_review": false,
      "unclassified_reason": null
    }
  ],
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-10-19",
  "license": {
    "attribution": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov): Product classification database (device/classification). Use does not imply FDA endorsement.",
    "name": "Public domain (CC0 1.0 Universal)",
    "url": "https://open.fda.gov/license/"
  },
  "next_skip": null,
  "observed_at_ms": 1793395070807,
  "pagination_truncated": false,
  "skip": 0,
  "source_url": "https://api.fda.gov/device/classification.json?search=product_code%3AQBJ&skip=0&limit=25",
  "total_matching": 1
}
```

### Device udi

- Capability: `devices/device_udi`
- Description: Look up devices in FDA's Global Unique Device Identification Database (GUDID) through openFDA by device identifier (DI) or full GS1 UDI, brand, company, model or product code: primary DI and the other identifiers with packaging, brand, version or model, catalog number, company and DUNS, description, commercial distribution status, product codes with class and regulation, premarket submissions (510(k) or PMA numbers), and Rx/OTC, kit, combination product, single use, sterility, MRI safety and latex labelling. A GS1 UDI's lot, serial, expiry and manufacturing date come back as production_identifiers. Newest published first. GMDN terms are not returned: GMDN content is licensed by The GMDN Agency and is not public domain.
- Instructions: Identify a device from a UDI barcode or DI, list a brand's or company's GUDID versions and models, or link a marketed device to its 510(k) or PMA. Use device_classifications for product codes and device_events for reports that cite a UDI-DI.
- Cost: 5 credits per call
- Capability file: [Device udi](https://alexandria.firecrawl.dev/agents/providers/fda-gov/devices/device_udi)

Accepted options:
- `brand` (string): Brand name words, matched as a phrase, e.g. Dexcom G7. Example: `<brand>`
- `company` (string): Labeler company words, e.g. Dexcom. Example: `<company>`
- `device_identifier` (string): Device identifier, e.g. 00386270003935, or a GS1 UDI in human-readable form, e.g. (01)00386270003935(17)251031(10)1824129005. Example: `<device_identifier>`
- `limit` (number): limit Example: `10`
- `model` (string): Version or model number, e.g. 9500-161. Example: `<model>`
- `product_code` (string): Three-letter FDA product code, e.g. QBJ. Pattern: ^ *[A-Za-z]{3} *$. Example: `<product_code>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "devices": [
    {
      "brand_name": "Dexcom G7 GSS (161)",
      "catalog_number": null,
      "commercial_distribution_end_date": null,
      "commercial_distribution_status": "In Commercial Distribution",
      "company_name": "Dexcom, Inc.",
      "device_count_in_base_package": 1,
      "device_description": "G7 GSS AR Patch",
      "identifiers": [
        {
          "id": "00386270003935",
          "issuing_agency": "GS1",
          "package_status": null,
          "quantity_per_package": null,
          "type": "Primary"
        }
      ],
      "is_combination_product": false,
      "is_kit": false,
      "is_otc": false,
      "is_rx": true,
      "is_single_use": true,
      "is_sterile": true,
      "labeled_contains_natural_rubber_latex": false,
      "labeler_duns_number": "123160736",
      "mri_safety": "MR Unsafe",
      "premarket_exempt": false,
      "premarket_submissions": [],
      "primary_di": "00386270003935",
      "product_codes": [
        {
          "code": "QBJ",
          "device_class": "2",
          "name": "Integrated Continuous Glucose Monitoring System, Factory Calibrated",
          "regulation_number": "862.1355"
        }
      ],
      "public_version_date": "2025-07-14",
      "publish_date": "2023-09-12",
      "record_status": "Published",
      "source_url": "https://api.fda.gov/device/udi.json?search=identifiers.id%3A%2200386270003935%22&limit=1",
      "sterilize_before_use": false,
      "version_or_model_number": "9500-161"
    }
  ],
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-10-01",
  "license": {
    "attribution": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov): Global Unique Device Identification Database, GUDID (device/udi), without GMDN content. Use does not imply FDA endorsement.",
    "name": "Public domain (CC0 1.0 Universal)",
    "url": "https://open.fda.gov/license/"
  },
  "next_skip": null,
  "observed_at_ms": 1793395070810,
  "pagination_truncated": false,
  "production_identifiers": {
    "expiration_date": "2025-10-31",
    "lot": "1824129005",
    "manufacturing_date": null,
    "serial": null
  },
  "skip": 0,
  "source_url": "https://api.fda.gov/device/udi.json?search=identifiers.id%3A%2200386270003935%22&sort=publish_date%3Adesc&skip=0&limit=10",
  "total_matching": 1
}
```

### Pma approvals

- Capability: `devices/pma_approvals`
- Description: Search FDA's premarket approval (PMA) database through openFDA: originals and supplements with PMA and supplement number, applicant, trade and generic name, product code, device class, advisory committee, supplement type and reason, dates received and decided, decision code and the approval order statement. Newest decision first.
- Instructions: Class III device approvals: a PMA's supplement history (pma_number P160048), PMA approvals for a device, applicant or product code in a period, or what a supplement changed. Use device_clearances for 510(k)s, device_classifications for what a product code is, device_udi for marketed versions and models, and device_events for reports on a device.
- Cost: 5 credits per call
- Capability file: [Pma approvals](https://alexandria.firecrawl.dev/agents/providers/fda-gov/devices/pma_approvals)

Accepted options:
- `applicant` (string): Applicant words, e.g. Senseonics. Example: `<applicant>`
- `decided_from` (string): Earliest decision date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<decided_from>`
- `decided_to` (string): Latest decision date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<decided_to>`
- `device` (string): Trade or generic name words, matched as a phrase, e.g. continuous glucose monitor. Example: `<device>`
- `limit` (number): limit Example: `25`
- `pma_number` (string): PMA number, e.g. P160048; add a supplement, e.g. P160048/S031, for one supplement. Pattern: ^ *[A-Za-z]? *[0-9]{6} *(/? *[Ss] *[0-9]{3})? *$. Example: `<pma_number>`
- `product_code` (string): Three-letter FDA product code, e.g. QBJ. Pattern: ^ *[A-Za-z]{3} *$. Example: `<product_code>`
- `skip` (number): skip Example: `0`
- `submission` (string): original: only original PMAs; supplement: only supplements. Example: `original`

Response schema example:
```json
{
  "approvals": [
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval of the revised protocol for the post-approval study (PAS) protocol.",
      "date_received": "2026-02-23",
      "decision_code": "APPR",
      "decision_date": "2026-03-19",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS031&limit=1",
      "supplement_number": "S031",
      "supplement_reason": "Postapproval Study Protocol",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense® Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval of the revised protocol for the post-approval study (PAS) protocol.",
      "date_received": "2025-02-25",
      "decision_code": "APPR",
      "decision_date": "2025-03-27",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS029&limit=1",
      "supplement_number": "S029",
      "supplement_reason": "Postapproval Study Protocol",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "to move finished Eversense Insertion Tool device manufacturing activities from one building to the neighboring building within the same establishment that has the same FEI. The Eversense Insertion Tool is a component of the Eversense E3 Continuous Glucose Monitoring System",
      "date_received": "2024-09-27",
      "decision_code": "OK30",
      "decision_date": "2024-10-23",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS028&limit=1",
      "supplement_number": "S028",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "to modify the Insertion Tools’s sterilization cycle parameters.  The Insertion Tools are components of the Eversense E3 Continuous Glucose Monitoring System",
      "date_received": "2024-01-23",
      "decision_code": "OK30",
      "decision_date": "2024-02-22",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS027&limit=1",
      "supplement_number": "S027",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for a manufacturing site located at RR Donnelley - Supply Chain Solutions, 1600 Disk Dr., Plover, WI 54467-3131, to perform kitting of the final components, labeling, storage, and distribution of the Eversense E3 CGM System.",
      "date_received": "2023-08-11",
      "decision_code": "APPR",
      "decision_date": "2023-12-05",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS026&limit=1",
      "supplement_number": "S026",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Scale-up of a Sensor subassembly manufacturing process and the addition of a new supplier for a critical component of the Eversense E3 Continuous Glucose Monitoring System.",
      "date_received": "2023-05-10",
      "decision_code": "OK30",
      "decision_date": "2023-06-09",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS025&limit=1",
      "supplement_number": "S025",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Addition of a new supplier for a critical component of the Eversense E3 Transmitter.  The transmitter is a component of the Eversense Continuous Glucose Monitoring System.",
      "date_received": "2023-04-14",
      "decision_code": "OK30",
      "decision_date": "2023-05-10",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS024&limit=1",
      "supplement_number": "S024",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense E3 CGM System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for modifying the Eversense E3 Transmitter, supporting mobile medical application, and the Instructions for Use for consistent use with the modified transmitter.",
      "date_received": "2023-01-31",
      "decision_code": "APPR",
      "decision_date": "2023-03-30",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS022&limit=1",
      "supplement_number": "S022",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "supplement_type": "Normal 180 Day Track",
      "trade_name": "Eversense® E3 Continuous Glucose Monitoring (CGM) System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for the Eversense® E3 Continuous Glucose Monitoring System for modifying the device to reduce the frequency of calibration.",
      "date_received": "2022-09-30",
      "decision_code": "APPR",
      "decision_date": "2023-03-29",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": "23M-1261",
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS021&limit=1",
      "supplement_number": "S021",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "supplement_type": "Panel Track",
      "trade_name": "Eversense® E3 Continuous Glucose Monitoring (CGM) System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval of the revised protocol for the post-approval study (PAS) protocol.",
      "date_received": "2023-02-22",
      "decision_code": "APPR",
      "decision_date": "2023-03-22",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS023&limit=1",
      "supplement_number": "S023",
      "supplement_reason": "Postapproval Study Protocol",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval of the revised protocol for the post-approval study (PAS) protocol.",
      "date_received": "2022-04-26",
      "decision_code": "APPR",
      "decision_date": "2022-05-24",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS019&limit=1",
      "supplement_number": "S019",
      "supplement_reason": "Postapproval Study Protocol",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense E3 Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval of the revised protocol for the post-approval study (PAS) protocol.",
      "date_received": "2022-04-05",
      "decision_code": "APPR",
      "decision_date": "2022-05-04",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS018&limit=1",
      "supplement_number": "S018",
      "supplement_reason": "Postapproval Study Protocol",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense E3 Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for the Eversense® E3 Continuous Glucose Monitoring System for expanding the indications for use and modifying the sensor design to allow use for up to 180 days.",
      "date_received": "2020-09-30",
      "decision_code": "APPR",
      "decision_date": "2022-02-10",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": "22M-0171",
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS016&limit=1",
      "supplement_number": "S016",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "supplement_type": "Panel Track",
      "trade_name": "Eversense® E3 Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "approval for adding a new component manufacturing line at a previously approved supplier",
      "date_received": "2020-11-12",
      "decision_code": "OK30",
      "decision_date": "2020-12-11",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS017&limit=1",
      "supplement_number": "S017",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160048/S006",
      "date_received": "2019-07-03",
      "decision_code": "APPR",
      "decision_date": "2019-11-25",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS012&limit=1",
      "supplement_number": "S012",
      "supplement_reason": "Postapproval Study Protocol",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for a manufacturing site located at Steris Isomedix Services, 3459 South Clinton Ave., South Plainfield, NJ 07080 for use as a sterilization site for the sensor insertion tools of the Eversense Continuous Glucose Monitoring System.",
      "date_received": "2019-08-27",
      "decision_code": "APPR",
      "decision_date": "2019-10-29",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS014&limit=1",
      "supplement_number": "S014",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for a design change to the sensor component of the Eversense Continuous Glucose Monitoring System.",
      "date_received": "2019-06-27",
      "decision_code": "APPR",
      "decision_date": "2019-08-29",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS011&limit=1",
      "supplement_number": "S011",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "supplement_type": "Normal 180 Day Track",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "New manufacturing site for the electronics assembly and encasement process for the sensor component of the Eversense continuous glucose monitoring system.",
      "date_received": "2019-07-31",
      "decision_code": "OK30",
      "decision_date": "2019-08-29",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS013&limit=1",
      "supplement_number": "S013",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Modification of equipment and processes used to encase the Eversense sensor.  The Eversense sensor is a component of the Eversense Continuous Glucose Monitoring system.",
      "date_received": "2019-06-24",
      "decision_code": "OK30",
      "decision_date": "2019-07-24",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS010&limit=1",
      "supplement_number": "S010",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Increased load size for a previously approved sterilization method, as well as approval for a new sealing device for the sterile barrier of the sensor component of the Eversense CGM system.",
      "date_received": "2019-05-28",
      "decision_code": "OK30",
      "decision_date": "2019-06-26",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS009&limit=1",
      "supplement_number": "S009",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "30-Day Notice",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for the Eversense CGM System.  The device is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.The system is intended to:1)\tProvide real-time glucose readings;2)\tProvide glucose trend information; and3)\tProvide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. The system is intended for single patient use.",
      "date_received": "2018-11-26",
      "decision_code": "APPR",
      "decision_date": "2019-06-06",
      "device_class": "3",
      "device_name": "Sensor, Glucose, Implanted, Non-Adjunctive Use",
      "docket_number": "19M-2753",
      "expedited_review": false,
      "generic_name": "Sensor, glucose, implanted, non-adjunctive use",
      "pma_number": "P160048",
      "product_code": "QHJ",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS006&limit=1",
      "supplement_number": "S006",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "supplement_type": "Panel Track",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval to add final packaging, storage, and distribution activities for the Eversense Continuous Glucose Monitoring System at Woodfield Distribution, LLC, Boca Raton, FL.",
      "date_received": "2018-08-27",
      "decision_code": "APPR",
      "decision_date": "2019-02-01",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS003&limit=1",
      "supplement_number": "S003",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval to label the Eversense Sensor as Magnetic Resonance (MR) Conditional.",
      "date_received": "2018-12-11",
      "decision_code": "APPR",
      "decision_date": "2019-01-28",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS008&limit=1",
      "supplement_number": "S008",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "supplement_type": "Real-Time Process",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for modification to the approved post-approval study protocol to include nurse practitioners and physicians assistants, in addition to physicians, as practitioners who will perform sensor insertions and removals.",
      "date_received": "2018-11-28",
      "decision_code": "APPR",
      "decision_date": "2019-01-15",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS007&limit=1",
      "supplement_number": "S007",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for a new LED for the Eversense sensor’s optical system.",
      "date_received": "2018-09-11",
      "decision_code": "APPR",
      "decision_date": "2018-12-07",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS005&limit=1",
      "supplement_number": "S005",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "supplement_type": "Real-Time Process",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for changing the shape of the antenna within the device sensor.",
      "date_received": "2018-09-07",
      "decision_code": "APPR",
      "decision_date": "2018-12-06",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS004&limit=1",
      "supplement_number": "S004",
      "supplement_reason": "Change Design/Components/Specifications/Material",
      "supplement_type": "Real-Time Process",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for modifying the instructions for use of the Eversense Continuous Glucose Monitoring System to specify that, in addition to physicians, nurse practitioners and physicians assistants who have completed the required training may insert and remove the Eversense sensor.",
      "date_received": "2018-08-07",
      "decision_code": "APPR",
      "decision_date": "2018-11-06",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS002&limit=1",
      "supplement_number": "S002",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "supplement_type": "Normal 180 Day Track",
      "trade_name": "Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval of the protocol for the post-approval study (PAS) protocol.",
      "date_received": "2018-07-20",
      "decision_code": "APPR",
      "decision_date": "2018-09-18",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": null,
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3AS001&limit=1",
      "supplement_number": "S001",
      "supplement_reason": "Postapproval Study Protocol",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "trade_name": "Eversense Continuous Glucose Monitoring System"
    },
    {
      "advisory_committee": "Clinical Chemistry",
      "applicant": "Senseonics, Incorporated",
      "approval_order_statement": "Approval for The Eversense CGM System.  The device is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 90 days.The system is intended to:1) Provide real-time glucose readings;2) Provide glucose trend information; and3)\tProvide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time.The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.",
      "date_received": "2016-10-26",
      "decision_code": "APPR",
      "decision_date": "2018-06-21",
      "device_class": "3",
      "device_name": "Continuous Glucose Monitor, Implanted, Adjunctive Use",
      "docket_number": "18M-2463",
      "expedited_review": false,
      "generic_name": "Continuous glucose monitor, implanted, adjunctive use",
      "pma_number": "P160048",
      "product_code": "QCD",
      "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048+AND+supplement_number%3A%22%22&limit=1",
      "supplement_number": null,
      "supplement_reason": null,
      "supplement_type": null,
      "trade_name": "EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM"
    }
  ],
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-10-19",
  "license": {
    "attribution": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov): Premarket approvals (device/pma). Use does not imply FDA endorsement.",
    "name": "Public domain (CC0 1.0 Universal)",
    "url": "https://open.fda.gov/license/"
  },
  "next_skip": null,
  "observed_at_ms": 1793395070803,
  "pagination_truncated": false,
  "skip": 0,
  "source_url": "https://api.fda.gov/device/pma.json?search=pma_number%3AP160048&sort=decision_date%3Adesc&skip=0&limit=50",
  "total_matching": 29
}
```

### Device events

- Capability: `adverse-events/device_events`
- Description: Search MAUDE, FDA's database of medical device reports (adverse events and malfunctions), through openFDA. One row per report: MDR report key and number, dates received and of the event, event type (death, injury, malfunction, other), report source, the devices involved (brand, generic name, manufacturer, model, lot, product code, device class, UDI-DI), product and patient problems, patient outcomes, remedial actions, the event description and the manufacturer narrative. Newest received first. With count_by it returns counts instead of reports: by event type, product problem, patient problem, manufacturer, brand name, product code or month received. Names, addresses and phone numbers of reporters and contacts are left out.
- Instructions: Post-market device safety: reports for a device or manufacturer in a period, deaths or injuries reported with a device, which problems are reported most (count_by), or one report by MDR key or report number. MAUDE reports are unverified and cannot show that a device caused an event or how often events happen. Use device_recalls for recalls, device_clearances for 510(k)s, pma_approvals for PMAs, device_udi to identify a device from its UDI, and drug_events for drug adverse events.
- Cost: 5 credits per call
- Capability file: [Device events](https://alexandria.firecrawl.dev/agents/providers/fda-gov/adverse-events/device_events)

Accepted options:
- `count_by` (string): Return counts of matching reports by this field instead of reports; limit caps the number of terms (not months), and skip must be 0. Example: `event_type`
- `device` (string): Brand or generic name words, matched as a phrase, e.g. Dexcom G7 or insulin pump. Example: `<device>`
- `event_type` (string): event_type Example: `death`
- `limit` (number): limit Example: `10`
- `manufacturer` (string): Device manufacturer words, e.g. Medtronic. Example: `<manufacturer>`
- `product_code` (string): Three-letter FDA product code, e.g. QBJ. Pattern: ^ *[A-Za-z]{3} *$. Example: `<product_code>`
- `query` (string): Words that must all appear in the narratives; wrap a phrase in double quotes, e.g. "sensor error" adhesive. Example: `<query>`
- `received_from` (string): Earliest date FDA received the report, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<received_from>`
- `received_to` (string): Latest date FDA received the report, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<received_to>`
- `report_id` (string): MDR report key, e.g. 23938785, or report number, e.g. 3004753838-2025-353233. Example: `<report_id>`
- `skip` (number): skip Example: `0`

Response schema example:
```json
{
  "count_by": "event_type",
  "counts": [
    {
      "count": 220783,
      "term": "Malfunction"
    },
    {
      "count": 5030,
      "term": "Injury"
    },
    {
      "count": 217,
      "term": "Other"
    },
    {
      "count": 27,
      "term": "Death"
    }
  ],
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-10-13",
  "license": {
    "attribution": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov): MAUDE medical device adverse event reports (device/event). Use does not imply FDA endorsement.",
    "name": "Public domain (CC0 1.0 Universal)",
    "url": "https://open.fda.gov/license/"
  },
  "next_skip": null,
  "observed_at_ms": 1793395070796,
  "pagination_truncated": false,
  "reports": [],
  "skip": 0,
  "source_url": "https://api.fda.gov/device/event.json?search=%28device.brand_name%3A%22Dexcom+G7%22+OR+device.generic_name%3A%22Dexcom+G7%22%29+AND+date_received%3A%5B20260101+TO+20261231%5D&count=event_type.exact&limit=10",
  "total_matching": 226057
}
```

### First generics

- Capability: `approvals/first_generics`
- Description: List CDER's first generic drug approvals for one calendar year (2016 on), from FDA's First Generic Drug Approvals page for that year: ANDA number, generic name, ANDA applicant, brand (reference) product with its application number where FDA links it, approval date and indication. Newest approval first.
- Instructions: Loss of exclusivity in practice: when the first generic of a brand was approved and by whom. One year per call, default the current year. Use paragraph_iv_certifications for patent challenges still pending, drug_applications for every ANDA, and novel_drug_approvals for new drugs.
- Cost: 5 credits per call
- Capability file: [First generics](https://alexandria.firecrawl.dev/agents/providers/fda-gov/approvals/first_generics)

Accepted options:
- `applicant` (string): ANDA applicant words, e.g. Teva. Example: `<applicant>`
- `limit` (number): limit Example: `25`
- `query` (string): Generic, brand or indication words, e.g. sitagliptin or Januvia. Example: `<query>`
- `skip` (number): skip Example: `0`
- `year` (number): Calendar year, 2016 to the current year; default the current year. Example: `2016`

Response schema example:
```json
{
  "approvals": [
    {
      "anda_number": "202327",
      "applicant": "Watson Laboratories Inc.",
      "approval_date": "2025-12-30",
      "brand_application_number": "021995",
      "brand_name": "Januvia Tablet",
      "generic_name": "Sitagliptin Phosphate Tablet",
      "indication": "Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
      "number": 91
    }
  ],
  "content_current_as_of": "2026-05-22",
  "license": {
    "attribution": "Source: U.S. Food and Drug Administration (FDA), First Generic Drug Approvals (CDER). Use does not imply FDA endorsement.",
    "name": "Public domain (U.S. Government work)",
    "url": "https://www.fda.gov/about-fda/about-website/website-policies"
  },
  "next_skip": null,
  "observed_at_ms": 1793392117564,
  "skip": 0,
  "source_url": "https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/2025-first-generic-drug-approvals",
  "total_matching": 1,
  "year": 2025
}
```

### Novel drug approvals

- Capability: `approvals/novel_drug_approvals`
- Description: List CDER's novel drug approvals (new molecular entities and new therapeutic biologics) for one calendar year, from FDA's yearly Novel Drug Approvals page: drug and active ingredient, approval date, the FDA-approved use on that date, FDA's running number, the Drug Trials Snapshot link when posted, and the application number where FDA links it. Newest approval first.
- Instructions: Launch tracking: which new drugs FDA approved this year or in a past year (2021 on), or when a given new drug was approved. One year per call, default the current year; filter with query. Use drug_applications for any approval including supplements, first_generics for first generic approvals, and cell_gene_therapies for CBER cell and gene therapies.
- Cost: 5 credits per call
- Capability file: [Novel drug approvals](https://alexandria.firecrawl.dev/agents/providers/fda-gov/approvals/novel_drug_approvals)

Accepted options:
- `limit` (number): limit Example: `25`
- `query` (string): Drug name, active ingredient or approved use words, e.g. suzetrigine or breast cancer. Example: `<query>`
- `skip` (number): skip Example: `0`
- `year` (number): Calendar year, 2021 to the current year; default the current year. Example: `2021`

Response schema example:
```json
{
  "approvals": [
    {
      "active_ingredient": "suzetrigine",
      "application_number": null,
      "approval_date": "2025-01-30",
      "approved_use": "To treat moderate to severe acute pain",
      "drug_name": "Journavx",
      "number": 3,
      "trials_snapshot_url": "https://www.fda.gov/drugs/drug-trials-snapshots/drug-trials-snapshots-journavx"
    }
  ],
  "content_current_as_of": "2026-07-08",
  "license": {
    "attribution": "Source: U.S. Food and Drug Administration (FDA), Novel Drug Approvals (CDER). Use does not imply FDA endorsement.",
    "name": "Public domain (U.S. Government work)",
    "url": "https://www.fda.gov/about-fda/about-website/website-policies"
  },
  "next_skip": null,
  "observed_at_ms": 1793393516201,
  "skip": 0,
  "source_url": "https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025",
  "total_matching": 1,
  "year": 2025
}
```

### Paragraph iv certifications

- Capability: `patent-challenges/paragraph_iv_certifications`
- Description: Search FDA's Paragraph IV patent certifications list: per reference listed drug and strength, the date FDA received the first substantially complete ANDA with a Paragraph IV certification, how many ANDAs, 180-day exclusivity status (eligible, extinguished, deferred, non_forfeiture), decision posting, first applicant approval and first commercial marketing dates, and when the last qualifying patent expires. Read from the current workbook FDA links from its patent certifications page; newest submission first.
- Instructions: Small-molecule loss of exclusivity: whether generic makers have challenged a brand's patents and when, whether 180-day exclusivity is still possible, and when the last qualifying patent expires. Use orange_book for an NDA's full patent and exclusivity listing, first_generics for first generics FDA approved, and purple_book for biologics.
- Cost: 5 credits per call
- Capability file: [Paragraph iv certifications](https://alexandria.firecrawl.dev/agents/providers/fda-gov/patent-challenges/paragraph_iv_certifications)

Accepted options:
- `application_number` (string): The RLD's NDA number, e.g. 208716 or NDA 208716. Example: `<application_number>`
- `drug` (string): Active ingredient or brand name words, e.g. abemaciclib or Verzenio. Example: `<drug>`
- `exclusivity_status` (string): 180-day exclusivity status FDA decided. Example: `eligible`
- `limit` (number): limit Example: `25`
- `patent_expires_from` (string): Earliest last-qualifying-patent expiration, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<patent_expires_from>`
- `patent_expires_to` (string): Latest last-qualifying-patent expiration, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<patent_expires_to>`
- `skip` (number): skip Example: `0`
- `submitted_from` (string): Earliest Paragraph IV submission date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<submitted_from>`
- `submitted_to` (string): Latest Paragraph IV submission date, YYYY-MM-DD. Pattern: ^[0-9]{4}-[0-9]{2}-[0-9]{2}$. Example: `<submitted_to>`

Response schema example:
```json
{
  "certifications": [
    {
      "anda_count": 1,
      "decision_posting_dates": [],
      "dosage_form": "Tablets",
      "drug_name": "Abemaciclib",
      "exclusivity_status": [],
      "first_applicant_approval_dates": [],
      "first_commercial_marketing_dates": [],
      "last_qualifying_patent_expirations": [
        "2031-09-28"
      ],
      "notes": [],
      "reference_listed_drug": "Verzenio",
      "rld_application_number": "208716",
      "strength": "50 mg, 100 mg, 150 mg, 200 mg",
      "submission_date": "2026-03-23",
      "submission_note": null
    }
  ],
  "file_url": "https://www.fda.gov/media/194880/download?attachment",
  "license": {
    "attribution": "Source: U.S. Food and Drug Administration (FDA), Paragraph IV Patent Certifications list. Use does not imply FDA endorsement.",
    "name": "Public domain (U.S. Government work)",
    "url": "https://www.fda.gov/about-fda/about-website/website-policies"
  },
  "list_date": "2026-10-27",
  "next_skip": null,
  "observed_at_ms": 1793392116446,
  "skip": 0,
  "source_url": "https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions",
  "total_matching": 1
}
```

### Substances

- Capability: `substances/substances`
- Description: Look up FDA's substance registry (UNIIs from the Global Substance Registration System) through openFDA by UNII, name or code: display name, substance class, definition level, molecular formula, weight, SMILES and stereochemistry for chemicals, every name with its type (official, systematic, brand, common, code), codes in other systems (CAS, WHO-ATC, MeSH, RxNorm RXCUI, NCI Thesaurus, PubChem and others) and related substances such as active moieties, salts and metabolites.
- Instructions: Resolve an ingredient to its UNII or a UNII to its names, map between CAS, ATC, MeSH and RxNorm codes, or find a salt's active moiety. A name must equal one of a substance's names apart from casing, so partial names find nothing; use unii when you have it. Use drug_labels or drug_ndc for products containing the substance.
- Cost: 5 credits per call
- Capability file: [Substances](https://alexandria.firecrawl.dev/agents/providers/fda-gov/substances/substances)

Accepted options:
- `code` (string): One code from another system, e.g. CAS 103-90-2 or RXCUI 161. Example: `<code>`
- `limit` (number): limit Example: `5`
- `name` (string): Exact substance name, e.g. acetaminophen or sodium chloride; tried as typed and in upper, lower, title and sentence case. Example: `<name>`
- `skip` (number): skip Example: `0`
- `unii` (string): UNII, e.g. 362O9ITL9D. Pattern: ^ *[A-Za-z0-9]{10} *$. Example: `<unii>`

Response schema example:
```json
{
  "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
  "last_updated": "2026-09-09",
  "license": {
    "attribution": "Data provided by the U.S. Food and Drug Administration (https://open.fda.gov): Substance data, UNII (other/substance). Use does not imply FDA endorsement.",
    "name": "Public domain (CC0 1.0 Universal)",
    "url": "https://open.fda.gov/license/"
  },
  "next_skip": null,
  "observed_at_ms": 1793395070816,
  "pagination_truncated": false,
  "skip": 0,
  "source_url": "https://api.fda.gov/other/substance.json?search=unii%3A%22362O9ITL9D%22&skip=0&limit=5",
  "substances": [
    {
      "codes": [
        {
          "code": "N02BE01",
          "code_system": "WHO-ATC",
          "type": "PRIMARY"
        },
        {
          "code": "QN02BE51",
          "code_system": "WHO-VATC",
          "type": "PRIMARY"
        },
        {
          "code": "QN02BE71",
          "code_system": "WHO-VATC",
          "type": "PRIMARY"
        },
        {
          "code": "QN02BE01",
          "code_system": "WHO-VATC",
          "type": "PRIMARY"
        },
        {
          "code": "103-90-2",
          "code_system": "CAS",
          "type": "PRIMARY"
        },
        {
          "code": "C198",
          "code_system": "NCI_THESAURUS",
          "type": "PRIMARY"
        },
        {
          "code": "NBK548162",
          "code_system": "LIVERTOX",
          "type": "PRIMARY"
        },
        {
          "code": "D000082",
          "code_system": "MESH",
          "type": "PRIMARY"
        },
        {
          "code": "2.1",
          "code_system": "WHO-ESSENTIAL MEDICINES LIST",
          "type": "PRIMARY"
        },
        {
          "code": "PARACETAMOL",
          "code_system": "WIKIPEDIA",
          "type": "PRIMARY"
        },
        {
          "code": "7.1",
          "code_system": "WHO-ESSENTIAL MEDICINES LIST",
          "type": "PRIMARY"
        },
        {
          "code": "21 CFR 310.201",
          "code_system": "CFR",
          "type": "PRIMARY"
        },
        {
          "code": "N02BE51",
          "code_system": "WHO-ATC",
          "type": "PRIMARY"
        },
        {
          "code": "N02BE71",
          "code_system": "WHO-ATC",
          "type": "PRIMARY"
        },
        {
          "code": "SUB09611MIG",
          "code_system": "EVMPD",
          "type": "PRIMARY"
        },
        {
          "code": "606318",
          "code_system": "EPA PESTICIDE CODE",
          "type": "PRIMARY"
        },
        {
          "code": "626",
          "code_system": "INN",
          "type": "PRIMARY"
        },
        {
          "code": "5239",
          "code_system": "IUPHAR",
          "type": "PRIMARY"
        },
        {
          "code": "ACETAMINOPHEN",
          "code_system": "WHO INTERNATIONAL PHARMACOPEIA",
          "type": "PRIMARY"
        },
        {
          "code": "161",
          "code_system": "RXCUI",
          "type": "PRIMARY"
        },
        {
          "code": "m1317",
          "code_system": "MERCK INDEX",
          "type": "PRIMARY"
        },
        {
          "code": "DB00316",
          "code_system": "DRUG BANK",
          "type": "PRIMARY"
        },
        {
          "code": "21 CFR 862.3030",
          "code_system": "CFR",
          "type": "PRIMARY"
        },
        {
          "code": "CHEMBL112",
          "code_system": "ChEMBL",
          "type": "PRIMARY"
        },
        {
          "code": "203-157-5",
          "code_system": "ECHA (EC/EINECS)",
          "type": "PRIMARY"
        },
        {
          "code": "1983",
          "code_system": "PUBCHEM",
          "type": "PRIMARY"
        },
        {
          "code": "8055-08-1",
          "code_system": "CAS",
          "type": "SUPERSEDED"
        },
        {
          "code": "3001",
          "code_system": "HSDB",
          "type": "PRIMARY"
        },
        {
          "code": "DTXSID2020006",
          "code_system": "EPA CompTox",
          "type": "PRIMARY"
        },
        {
          "code": "21 CFR 341.40",
          "code_system": "CFR",
          "type": "PRIMARY"
        },
        {
          "code": "N02AJ01",
          "code_system": "WHO-ATC",
          "type": "PRIMARY"
        },
        {
          "code": "N02AJ13",
          "code_system": "WHO-ATC",
          "type": "PRIMARY"
        },
        {
          "code": "N02AJ17",
          "code_system": "WHO-ATC",
          "type": "PRIMARY"
        },
        {
          "code": "N02AJ06",
          "code_system": "WHO-ATC",
          "type": "PRIMARY"
        },
        {
          "code": "C2356",
          "code_system": "NCI_THESAURUS",
          "type": "CONCEPT"
        },
        {
          "code": "75071-1",
          "code_system": "LOINC",
          "type": "PRIMARY"
        },
        {
          "code": "362O9ITL9D",
          "code_system": "FDA UNII",
          "type": "PRIMARY"
        },
        {
          "code": "1003009",
          "code_system": "RS_ITEM_NUM",
          "type": "PRIMARY"
        },
        {
          "code": "Acetaminophen",
          "code_system": "LACTMED",
          "type": "PRIMARY"
        },
        {
          "code": "52",
          "code_system": "DRUG CENTRAL",
          "type": "PRIMARY"
        },
        {
          "code": "46195",
          "code_system": "CHEBI",
          "type": "PRIMARY"
        },
        {
          "code": "109028",
          "code_system": "NSC",
          "type": "PRIMARY"
        },
        {
          "code": "100000090270",
          "code_system": "SMS_ID",
          "type": "PRIMARY"
        },
        {
          "code": "3991",
          "code_system": "NSC",
          "type": "PRIMARY"
        },
        {
          "code": "362O9ITL9D",
          "code_system": "DAILYMED",
          "type": "PRIMARY"
        }
      ],
      "definition_level": "COMPLETE",
      "molecular_formula": "C8H9NO2",
      "molecular_weight": 151.1629,
      "name": "Acetaminophen",
      "names": [
        {
          "name": "4′-Hydroxyacetanilide",
          "type": "sys"
        },
        {
          "name": "ACEPHEN",
          "type": "bn"
        },
        {
          "name": "ALLAY COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "ANEXSIA COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "ANOQUAN COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "APAP",
          "type": "cn"
        },
        {
          "name": "Acetamide, N-(4-hydroxyphenyl)-",
          "type": "sys"
        },
        {
          "name": "Acetaminophen",
          "type": "of"
        },
        {
          "name": "Acetaminophen [HSDB]",
          "type": "cn"
        },
        {
          "name": "Acetaminophen [JAN]",
          "type": "cn"
        },
        {
          "name": "Acetaminophen [MI]",
          "type": "cn"
        },
        {
          "name": "Acetaminophen [ORANGE BOOK]",
          "type": "cn"
        },
        {
          "name": "Acetaminophen [USP IMPURITY]",
          "type": "cn"
        },
        {
          "name": "Acetaminophen [USP MONOGRAPH]",
          "type": "cn"
        },
        {
          "name": "Acetaminophen [USP-RS]",
          "type": "cn"
        },
        {
          "name": "Acetaminophen [VANDF]",
          "type": "cn"
        },
        {
          "name": "BANCAP COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "BANCAP HC COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "BIOCETAMOL",
          "type": "cn"
        },
        {
          "name": "BUCET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "BUTAPAP COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "CO-GESIC COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "CODRIX COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "COMBOGESIC COMPONENT ACETAMINOPHEN",
          "type": "bn"
        },
        {
          "name": "COMBOGESIC IV COMPONENT ACETAMINOPHEN",
          "type": "bn"
        },
        {
          "name": "DAFALGAN",
          "type": "bn"
        },
        {
          "name": "DARVOCET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "DHC PLUS COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "DOLENE AP-65 COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "DOLIPRANE",
          "type": "bn"
        },
        {
          "name": "DRIXORAL PLUS COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "DURADYNE DHC COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "EFFERALGAN",
          "type": "bn"
        },
        {
          "name": "ESGIC COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "EXCEDRIN COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "FEMCET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "FIORICET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "HY-PHEN COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "INJECTAPAP",
          "type": "bn"
        },
        {
          "name": "LORCET-HD COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "LORTAB COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "MEDIGESIC PLUS COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "N-Acetyl-p-aminophenol",
          "type": "cn"
        },
        {
          "name": "NEOPAP",
          "type": "bn"
        },
        {
          "name": "NORCET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "NORCO COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "NSC-109028",
          "type": "cd"
        },
        {
          "name": "NSC-3991",
          "type": "cd"
        },
        {
          "name": "OFIRMEV",
          "type": "bn"
        },
        {
          "name": "OXYCET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "P-HYDROXY-ACETANILID",
          "type": "cn"
        },
        {
          "name": "PANADOL",
          "type": "bn"
        },
        {
          "name": "PARACETAMOL",
          "type": "of"
        },
        {
          "name": "PARACETAMOL [EP MONOGRAPH]",
          "type": "cn"
        },
        {
          "name": "PARACETAMOL [IARC]",
          "type": "cn"
        },
        {
          "name": "PARACETAMOL [MART.]",
          "type": "cn"
        },
        {
          "name": "PARACETAMOL [WHO-IP]",
          "type": "cn"
        },
        {
          "name": "PARACETAMOLUM [WHO-IP LATIN]",
          "type": "cn"
        },
        {
          "name": "PERCOCET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "PERFALGAN",
          "type": "bn"
        },
        {
          "name": "PHENAPHEN",
          "type": "cn"
        },
        {
          "name": "PHRENILIN COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "Paracetamol [WHO-DD]",
          "type": "cn"
        },
        {
          "name": "ROXICET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "ROXILOX COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "SEDAPAP COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "SYNALGOS-DC-A COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "TALACEN COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "TENCON COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "TREZIX COMPONENT ACETAMINOPHEN",
          "type": "bn"
        },
        {
          "name": "TRIAD COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "TRIAPRIN COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "TYCOLET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "TYLENOL",
          "type": "bn"
        },
        {
          "name": "TYLOX COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "ULTRACET COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "VERMIDON",
          "type": "cn"
        },
        {
          "name": "VICODIN COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "WYGESIC COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "XARTEMIS COMPONENT ACETAMINOPHEN",
          "type": "bn"
        },
        {
          "name": "ZYDONE COMPONENT ACETAMINOPHEN",
          "type": "cn"
        },
        {
          "name": "paracetamol [INN]",
          "type": "cn"
        }
      ],
      "relationships": [
        {
          "name": "Acetaminophen",
          "type": "ACTIVE MOIETY",
          "unii": "362O9ITL9D"
        },
        {
          "name": "p-Aminophenol",
          "type": "IMPURITY->PARENT",
          "unii": "R7P8FRP05V"
        },
        {
          "name": "ACETIMIDOQUINONE",
          "type": "METABOLITE TOXIC->PARENT",
          "unii": "G6S9BN13TI"
        },
        {
          "name": "Acetaminophen",
          "type": "BASIS OF STRENGTH->SUBSTANCE",
          "unii": "362O9ITL9D"
        },
        {
          "name": "P-CHLOROACETANILIDE",
          "type": "IMPURITY->PARENT",
          "unii": "6I0LI34G5J"
        },
        {
          "name": "ACETAMINOPHEN MERCAPTURATE",
          "type": "METABOLITE INACTIVE->PARENT",
          "unii": "R86SEU3G6U"
        },
        {
          "name": "3-HYDROXYACETAMINOPHEN",
          "type": "METABOLITE->PARENT",
          "unii": "IX22A3NJLN"
        },
        {
          "name": "PARAPROPAMOL",
          "type": "IMPURITY->PARENT",
          "unii": "I729P6N0P7"
        },
        {
          "name": "ACETAMINOPHEN GLUCURONIDE",
          "type": "METABOLITE INACTIVE->PARENT",
          "unii": "8BE7G9R76X"
        },
        {
          "name": "Acetaminophen sulfate",
          "type": "METABOLITE INACTIVE->PARENT",
          "unii": "S6002H6J9F"
        },
        {
          "name": "3-CYSTEINYLACETAMINOPHEN",
          "type": "METABOLITE INACTIVE->PARENT",
          "unii": "6Q2X58Y8BP"
        },
        {
          "name": "CYTOCHROME P450 1A2",
          "type": "METABOLIC ENZYME->SUBSTRATE",
          "unii": "VK4SQL11C0"
        },
        {
          "name": "CYTOCHROME P450 2E1",
          "type": "METABOLIC ENZYME->SUBSTRATE",
          "unii": "03BYF220B6"
        },
        {
          "name": "3-METHYL-THIOACETAMINOPHEN GLUCURONIDE",
          "type": "METABOLITE->PARENT",
          "unii": "57DZD477I1"
        },
        {
          "name": "PLASMA PROTEIN FRACTION (HUMAN)",
          "type": "BINDER->LIGAND",
          "unii": "6D53G0FD0Z"
        },
        {
          "name": "4'-HYDROXYACETOPHENONE OXIME",
          "type": "IMPURITY->PARENT",
          "unii": "FQB3AM10WC"
        },
        {
          "name": "HYDROXYACETOPHENONE",
          "type": "IMPURITY->PARENT",
          "unii": "G1L3HT4CMH"
        },
        {
          "name": "AM-404",
          "type": "METABOLITE ACTIVE->PARENT",
          "unii": "XVJ94H0U21"
        },
        {
          "name": "4-ACETYLAMINO-2-CHLOROPHENOL",
          "type": "IMPURITY->PARENT",
          "unii": "E11430J0W2"
        },
        {
          "name": "ARYLAMINE N-ACETYLTRANSFERASE 2",
          "type": "METABOLIC ENZYME->SUBSTRATE",
          "unii": "R17Q1X3RGX"
        },
        {
          "name": "DIACETAMATE",
          "type": "IMPURITY->PARENT",
          "unii": "BFG1TY61BG"
        },
        {
          "name": "PHENOL, 4,4'-IMINOBIS-",
          "type": "IMPURITY->PARENT",
          "unii": "GT5H6Q4HYA"
        },
        {
          "name": "4,4'-OXYBIS(ACETANILIDE)",
          "type": "IMPURITY->PARENT",
          "unii": "LT12J9ECA9"
        },
        {
          "name": "2'-HYDROXYACETOPHENONE",
          "type": "IMPURITY->PARENT",
          "unii": "3E533Z76W0"
        },
        {
          "name": "VORINOSTAT",
          "type": "PARENT->METABOLITE",
          "unii": "58IFB293JI"
        },
        {
          "name": "POTASSIUM 4-ACETAMIDOPHENOLATE",
          "type": "SALT/SOLVATE->PARENT",
          "unii": "WVH4R62LA6"
        },
        {
          "name": "ACETAMINOPHEN DIMER",
          "type": "IMPURITY->PARENT",
          "unii": "3UMW7AU2LD"
        },
        {
          "name": "p-Aminophenol",
          "type": "METABOLITE ACTIVE->PARENT",
          "unii": "R7P8FRP05V"
        },
        {
          "name": "4-HYDROXYACETANILIDE SODIUM",
          "type": "SALT/SOLVATE->PARENT",
          "unii": "V9E6HW6ZAG"
        },
        {
          "name": "3-GLUTATHIONYLACETAMINOPHEN",
          "type": "METABOLITE->PARENT",
          "unii": "T3YTW02XCU"
        }
      ],
      "smiles": "CC(=O)Nc1ccc(cc1)O",
      "source_url": "https://api.fda.gov/other/substance.json?search=unii%3A%22362O9ITL9D%22&limit=1",
      "stereochemistry": "ACHIRAL",
      "substance_class": "chemical",
      "unii": "362O9ITL9D",
      "version": "163"
    }
  ],
  "total_matching": 1
}
```