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FDA Drug Approvals

Every drug FDA has approved arrives as an application — a new drug application for a small molecule, a biologics license application for a biologic — and FDA keeps the file open for the life of the drug. The original approval has a date. So does every change approved since. Each application below has its own page with both.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Listed here are applications FDA records as having an approved original submission with a date on it. Generic applications are excluded — an ANDA is approved against somebody else’s drug, and its date is not the date that drug was approved. An application missing from this list has no approval on record, which is a different claim from never approved: how completely openFDA carries applications that were never approved is not something we have measured.