FDA.reportPublic FDA data

Application 211442

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPAGLIFLOZINDAPAGLIFLOZINTABLET;ORAL40MGNoNo
002DAPAGLIFLOZINDAPAGLIFLOZINTABLET;ORAL80MGNoNo

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAPAGLIFLOZINDAPAGLIFLOZINAlembic Pharmaceuticals Limitedd44f7eed-dd51-40d1-8408-8fb331e1f1f62026-04-21Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINApotex Corp.bd9766c5-104f-4636-897d-b6c92eb94f182026-04-10Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINZydus Lifesciences Limiteddb668c5c-2d49-41c8-8ffd-c2b2652b621a2026-04-06Name fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINBryant Ranch Prepack979205ee-b0b8-4483-ae61-f283f750bb7f2024-08-08Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINA-S Medication Solutions82cdd5ad-df2b-4bdd-a3a6-a059040100b42024-06-28Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINA-S Medication Solutions87521963-0d2a-4a2a-89c6-d50e8582419e2024-06-28Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN

Reported adverse events (FAERS/openFDA)#

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