FDA.reportPublic FDA data

Application 212615

Type
ANDA
Sponsor
GRANULES INDIA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIRFENIDONEPIRFENIDONETABLET;ORAL267MGNoNo
002PIRFENIDONEPIRFENIDONETABLET;ORAL801MGNoNo

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 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIRFENIDONEPIRFENIDONENovadoz Pharmaceuticals LLC741d1b9c-e281-4eca-b327-e25e823130062024-07-23Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONENorthstar Rx LLC5d0eee8c-dc7d-4444-8684-e9c9335291c82024-03-08Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAlembic Pharmaceuticals Inc.9214862e-9ef7-4370-856a-f5697978270a2023-12-06Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEScieGen Pharmaceuticals, Inc.1fbdb556-b164-4e0b-a95e-6004d50e33642023-11-09Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEScieGen Pharmaceuticals, Inc.155b948e-47f5-4741-8e82-2ed65ccfab7d2023-11-08Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PirfenidonePIRFENIDONECamber Pharmaceuticals, Inc.a7f3485e-9dcc-45db-9b9c-74c70e22c4bb2023-05-11Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONESandoz Inc7f5f7cc9-394e-4da0-87eb-84cfff9707a32023-04-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLCa235768d-d26d-4ded-ae75-53e93310ff6a2023-04-10Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAlembic Pharmaceuticals Limited6e4f991a-c9e3-4121-97d0-d07954f173362023-03-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEEXELAN PHARMACEUTICALS INC.1709582c-9975-4dc1-8181-2501ee670eef2023-01-20Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
PirfenidonePIRFENIDONECipla USA Inc.1927bf5d-1ef3-4a36-8dac-dc0a45b72fec2022-08-26Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEEXELAN PHARMACEUTICALS INC.c171e4af-1619-4712-958f-ef96adfede372022-08-08Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONECipla USA Inc.16fca4fc-b641-4ee8-a2ee-a35189ce1f3b2022-08-03Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE

Reported adverse events (FAERS/openFDA)#

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