FDA.reportPublic FDA data

Application 216278

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIOPRONINTIOPRONINTABLET, DELAYED RELEASE;ORAL300MGNoNo
002TIOPRONINTIOPRONINTABLET, DELAYED RELEASE;ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216278-001TIOPRONINTIOPRONIN300MGTABLET, DELAYED RELEASE / ORAL2023-08-15
A216278-002TIOPRONINTIOPRONIN100MGTABLET, DELAYED RELEASE / ORAL2025-08-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A216278-001TIOPRONIN300MGTABLET, DELAYED RELEASE / ORAL2023-08-15a50c72e98297…
2026-08-01 22:54:322026-06A216278-002TIOPRONIN100MGTABLET, DELAYED RELEASE / ORAL2025-08-29a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tioproninTIOPRONINAmneal Pharmaceuticals NY LLCce5b1f97-5b3c-40b6-b1c4-1d36025be1b82023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216278
application number: ANDA216278