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US Drug Approvals — NDA, ANDA & BLA Application Tracker

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US drug applications (NDA, ANDA, BLA): sponsor, brand and generic names, ingredients, dosage form, approval and latest submission dates, letter and label links. Filter by drug, sponsor, dates. Data: openFDA (CC0), not affiliated.

Pricing

from $1.50 / 1,000 result returneds

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plaindata

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Monthly active users

10 days ago

Last modified

Input examples

{ "approvedFrom": "2026-01-01", "newApprovalsOnly": true, "maxItems": 100 }
{ "activeIngredient": "SEMAGLUTIDE" }
{ "sponsor": "PFIZER", "approvedFrom": "2026-06-01" }

Output (one row per application)

Field	Meaning
applicationNumber, sponsorName	NDA/ANDA/BLA number and company
brandNames, genericNames, activeIngredients	Product identity
dosageForms, routes, marketingStatuses	Product details
originalApprovalDate	First approval of the original application
latestSubmissionType/Number/Status/Date/Class, reviewPriority	Most recent submission in your date window
latestDocuments	Letter / label / review PDF links
pharmacologicClass, manufacturerNames, submissionsCount, drugsAtFdaUrl, source	Extra context

Data source & licence

openFDA (api.fda.gov). openFDA data are public domain (CC0): "You can copy, modify, distribute and perform the work, even for commercial purposes, all without asking permission." Sponsors are companies — no personal data.

Notes

Without an API key openFDA limits daily requests per IP; add your free key for heavy use. Not affiliated with or endorsed by the U.S. FDA. Do not rely on openFDA data for medical decisions.

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