FDA.reportPublic FDA data

Application 200835

Type
ANDA
Sponsor
WATSON LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROBROMIDEBUPROPION HYDROBROMIDETABLET, EXTENDED RELEASE; ORAL174MGNoNo
002BUPROPION HYDROBROMIDEBUPROPION HYDROBROMIDETABLET, EXTENDED RELEASE; ORAL522MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupropion HydrobromideBUPROPION HYDROBROMIDEOceanside Pharmaceuticals3ec04240-baef-44d7-8d73-a181171eec432026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bupropion Hydrobromide
generic name: BUPROPION HYDROBROMIDE
AplenzinBUPROPION HYDROBROMIDEBausch Health US, LLC6494d2d9-0ce4-4126-b1c7-49684395942b2026-03-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: BUPROPION HYDROBROMIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.