FDA Small Molecule Approval Registry
All FDA-approved small molecules with patent listings, exclusivity codes, therapeutic equivalence ratings, and IRA 7-year eligibility clock pre-calculated.
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Overview
All FDA-approved small molecules with patent listings, exclusivity codes, therapeutic equivalence ratings, and IRA 7-year eligibility clock pre-calculated.
Analyze approval, label, safety, REMS, biologic, small molecule, and NDC records without source-specific parsing work.
Join NDA, BLA, NDC, RxCUI, UNII, SPL set ID, patent, and exclusivity identifiers through the drug identity spine.
Model regulatory timelines, indication expansion, label change velocity, and eligibility clocks with curated fields.
Trace every normalized attribute back to the official FDA or NLM source authority.
Source authority
FDA Orange Book
Freshness
Last refreshed 2026-09-01
Monthly
Coverage
40K+ products
2 delivery tables