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#

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAPAGLIFLOZINDAPAGLIFLOZINBryant Ranch Prepack05c3cf00-8c2a-4227-958a-fa5db34512b02026-09-08Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINBiocon Pharma Inc.828f1004-3647-9a13-8008-c4b3759ecfd02026-08-21Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DapagliflozinDAPAGLIFLOZINSandoz Inc8296f538-4c23-4d6c-be53-8005b83c24b72026-07-30Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin
generic name: DAPAGLIFLOZIN
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
DapagliflozinDAPAGLIFLOZINAjanta Pharma USA Inc.f615d81e-d1e8-4561-a4d9-286c615d3bd22026-07-06Warnings, 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
DapagliflozinDAPAGLIFLOZINLupin Pharmaceuticals, Inc.08baca21-e39e-4e61-961f-d89432fe80072026-06-26Warnings, 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
DAPAGLIFLOZINDAPAGLIFLOZINCipla USA Inc.a2f86c0a-ce78-4d06-b5d8-ed457c8e36142026-06-22Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
DAPAGLIFLOZINDAPAGLIFLOZINTeva Pharmaceuticals, Inc.0406a1c0-56b1-4ea1-95ae-00357ac1ba7e2026-06-21Warnings, 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
DAPAGLIFLOZINDAPAGLIFLOZINPrasco Laboratories3aba33aa-f8c6-4b10-85c8-dfa14578d07c2026-06-03Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN
generic name: DAPAGLIFLOZIN
FARXIGADAPAGLIFLOZINAstraZeneca Pharmaceuticals LP72ad22ae-efe6-4cd6-a302-98aaee423d692026-06-03Warnings, Adverse reactionsName fallback
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

Documents#

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