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AGENTIC Data Mining
● Public TOOL fda.approvals LAST SYNC 2026-07-19T11:24:34Z

FDA drug approvals

One row per application-submission approval event: NDA/ANDA/BLA originals and their approved supplements, with sponsor, brand/generic names, dosage form, route, active ingredients, submission class, and an is_novel flag for new molecular entities / novel biologics. Join generic_name to health.trials interventions to trace trial → approval, or sponsor_name to fda.warning_letters for regulatory risk.

Records

186,409

Approval-submission events, structured JSON

History

1939–2026

1939-02-09 through 2026-07-15

New records

Nightly batch

openFDA Drugs@FDA export refresh

Freshness

Daily

JSON · Public · included in subscription

Live-verified 2026-07-19: 186,409 records synced, 1939-02-09 through 2026-07-15.

Query parameters

sponsorstring

Applicant/sponsor company, partial match

drugstring

Brand OR generic name, partial match (searches both)

is_novelboolean

Filter to new molecular entities / novel biologics

submission_typestring

ORIG (original approval) or SUPPL (supplement), exact match

approval_after / approval_beforeISO date

Approval-date window

limitinteger

Max records to return (default 25, max 50)

Also available: brand, generic (narrower single-field matches). Results are ordered by approval_date desc.

Example call

Request · fda.approvals 
{
  "tool": "fda.approvals",
  "params": {
    "is_novel": true,
    "approval_after": "2025-01-01",
    "limit": 25
  }
}
Try in playground

Schema

Field Type Description
application_number / application_typestringNDA/ANDA/BLA number and type
sponsor_namestringApplicant company — join key to fda.warning_letters
submission_type / submission_numberstringORIG or SUPPL, and the submission sequence number
submission_class_descriptionstringFDA's own classification of the submission
review_prioritystringPriority vs. standard review
approval_date / approval_yeardate / integerApproval date; default sort key
brand_name / generic_name / substance_namestringMarketed brand, generic, and active substance names — generic_name is the join key to health.trials
dosage_form / route / active_ingredientsstringFormulation detail
marketing_statusstringCurrent marketing status
is_novelbooleanNew molecular entity / novel biologic flag, filterable
is_original_approval / is_orphanbooleanFirst approval and orphan-drug-designation flags
approval_letter_urlstringLink to the FDA approval letter — cite this

Sample record

Sample · fda.approvals 
{
  "application_number": "NDA218000",
  "application_type": "NDA",
  "sponsor_name": "EXAMPLE PHARMA",
  "submission_type": "ORIG",
  "submission_number": "1",
  "submission_class_description": "Type 1 - New Molecular Entity",
  "review_priority": "PRIORITY",
  "approval_date": "2024-06-10",
  "approval_year": 2024,
  "brand_name": "NOVELIQ",
  "generic_name": "EXAMPLICIB",
  "dosage_form": "TABLET",
  "route": "ORAL",
  "marketing_status": "Prescription",
  "is_novel": true,
  "is_original_approval": true,
  "is_orphan": false
}

Use it for

  • New molecular entities by sponsor and year, filtered on is_novel
  • Trace a clinical trial to its approval by joining generic_name to health.trials interventions
  • Regulatory-risk screen a sponsor by cross-referencing sponsor_name against fda.warning_letters

Related in Corporate, Legal & Labor

● Public Daily

ClinicalTrials.gov registrations

health.trials

Trial registrations for the drug candidates behind these approvals — join by generic_name/intervention.

480K records · 2016–present

Included in subscription View dataset
● Public Daily

FDA warning letters

fda.warning_letters

Active FDA enforcement against a sponsor — join by sponsor_name/company_name for a regulatory-risk screen.

964 letters · 2021–present

Included in subscription View dataset
● Public Daily

NIH research grants

health.nih_grants

SBIR/STTR-funded biotechs — trace an early NIH grant through to the drug it ultimately got approved.

791K records · FY1970–present

Included in subscription View dataset