FDA.reportPublic FDA data

Application 216204

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFEN AND DIPHENHYDRAMINE CITRATEDIPHENHYDRAMINE CITRATE; IBUPROFENTABLET;ORAL38MG;200MGNoNo

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
A216204-001IBUPROFEN AND DIPHENHYDRAMINE CITRATEDIPHENHYDRAMINE CITRATE; IBUPROFEN38MG;200MGTABLET / ORAL2022-05-31

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 22:54:322026-06A216204-001IBUPROFEN AND DIPHENHYDRAMINE CITRATE38MG;200MGTABLET / ORAL2022-05-31a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMAZON BASIC CARE IBUPROFEN PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEAmazon.com Services LLC10ec6386-db13-a9dd-e063-6294a90a82612026-03-18WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEBetter Living Brands, LLCfcfb044d-f6b9-5c43-e053-6394a90ac4172024-10-29WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKROGER COMPANY15e649c4-d75f-e8c1-e063-6294a90a77472024-07-26WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEAurohealth LLC21c1f5c5-19fa-4a59-bad3-ea85fd37471b2022-06-03WarningsExact identifier
application applno (ANDA): 216204
application number: ANDA216204
ndc (product): 58602-867

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58602-867Ibuprofen and Diphenhydramine CitrateIbuprofen and Diphenhydramine CitrateAurohealth LLCANDACurrent