FDA.reportPublic FDA data

Application 219053

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFENTABLET;ORAL250MG;125MGNoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219053-001ACETAMINOPHEN AND IBUPROFENACETAMINOPHEN; IBUPROFEN250MG;125MGTABLET / ORAL2026-01-02

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
2026-02-19 14:30 UTC2026-02A219053-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2026-01-02011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219053-001ACETAMINOPHEN AND IBUPROFEN250MG;125MGTABLET / ORAL2026-01-02a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSSun Pharmaceutical Industries, Inc.2a31a975-72f9-2a16-e063-6394a90a81492026-03-10WarningsExact identifier
application applno (ANDA): 219053
application number: ANDA219053