FDA.reportPublic FDA data

Application 211564

Type
ANDA
Sponsor
GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPAGLIFLOZINDAPAGLIFLOZINUNKNOWNUNKNOWNNoNo
002DAPAGLIFLOZINDAPAGLIFLOZINTABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DapagliflozinDAPAGLIFLOZINAurobindo Pharma Limitedf56593f7-588e-489d-9fad-b459e90dab182026-07-17Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
FARXIGADAPAGLIFLOZINA-S Medication Solutions01f90c94-71cb-4a1f-81ff-8004b850529b2026-07-10Warnings, Adverse reactionsName fallback
generic name: DAPAGLIFLOZIN
dapagliflozinDAPAGLIFLOZINMacleods Pharmaceuticals Limited91373924-66dc-4277-aaf2-8536e81a0e4d2026-07-09Warnings, Adverse reactionsName fallback
brand name: dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINFlorida Pharmaceutical Products, LLC20a83ea2-6ad8-4bbb-b516-73c0a9e373992026-07-02Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINANI Pharmaceuticals, Inc.6425d240-5dd9-4a2c-9348-f8a8597028502026-06-29Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINAscend Laboratories, LLCb6b8a10c-64c3-4856-8961-d72d68784f5d2026-06-25Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINAlembic Pharmaceuticals Inc.840e2146-2383-489b-bcc4-fecfe986685a2026-06-23Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINZydus Pharmaceuticals USA Inc.17586ec6-0104-4b08-ad87-12a837568d6c2026-06-22Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINNovadoz Pharmaceuticals LLC107b4d25-4764-42b7-80e3-9aaff20865ed2026-06-17Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LP72ad22ae-efe6-4cd6-a302-98aaee423d692026-06-03Warnings, Adverse reactionsName fallback
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINPrasco Laboratories3aba33aa-f8c6-4b10-85c8-dfa14578d07c2026-06-03Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINAvKARE52a778e7-6044-2049-e063-6294a90aa0b72026-05-27Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsaddc6ead-f9e3-4b40-aed1-bc008a5c9b0f2026-05-18Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINA-S Medication Solutionsc4264ff6-5199-49e9-91d3-3ad67b42f88d2026-05-18Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
FARXIGADAPAGLIFLOZINREMEDYREPACK INC.ef9e9c8c-5460-4193-952a-0c249dd071bd2026-04-24Warnings, Adverse reactionsName fallback
generic name: DAPAGLIFLOZIN
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
DAPAGLIFLOZINDAPAGLIFLOZINCipla USA Inc.a2f86c0a-ce78-4d06-b5d8-ed457c8e36142026-04-08Warnings, 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
DapagliflozinDAPAGLIFLOZINLupin Pharmaceuticals, Inc.08baca21-e39e-4e61-961f-d89432fe80072026-04-02Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63097ORIG2020-05-19