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 1 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PirfenidonePIRFENIDONEAurobindo Pharma Limited3115f15f-171c-4266-8dc8-5655f56e6acc2026-04-22Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAvKARE07ff87b3-0a88-15b4-e063-6294a90a72ab2026-01-14Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAvKARE08046b49-a8b3-a78d-e063-6394a90a80fa2026-01-14Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PIRFENIDONEPIRFENIDONEAccord Healthcare Inc.fab59395-1c5d-4c64-ba47-34d75736e9832025-12-17Warnings, Adverse reactionsName fallback
brand name: PIRFENIDONE
generic name: PIRFENIDONE
ESBRIETPIRFENIDONEGenentech, Inc.2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e2025-12-05Warnings, Adverse reactionsName fallback
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEGolden State Medical Supply, Inc.1b3261fe-c066-6e86-e063-6294a90a675c2025-11-24Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepack33f1ca21-4c08-4103-889d-1d9c929b5fad2025-10-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepackbd3483bf-96e9-4d6b-a844-63bd002c48a42025-10-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEANI Pharmaceuticals, Inc.976620bb-c10e-4b13-8a97-7025fda6b7d52025-09-17Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAurobindo Pharma Limited50958060-c904-4374-997d-59df54007fa42025-08-13Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepackbfcb3157-cfa1-493d-9598-1e7fd3d355d92025-08-07Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEBryant Ranch Prepack9bdc7ed9-e51c-4101-a792-31619f05136b2025-08-07Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONELaurus Labs Limited29b0fd0e-5a2b-4da7-8524-177dc28bf55e2025-07-22Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
ESBRIETPIRFENIDONELegacy Pharma USA Inc.81f17f7d-cb04-4052-8682-dd3e330210ab2025-06-09Warnings, Adverse reactionsName fallback
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEMicro Labs Limited1abc06c7-6a45-4a0b-b2da-c228aaa137ed2025-06-04Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLC94362a07-7c64-42ce-adef-f49585af55d62025-05-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLC1d4d7aa2-1248-4639-baf5-5e2ae72cbcd82025-02-28Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONEAmneal Pharmaceuticals NY LLCea26490e-fd32-4807-8556-eb6f5f963c232024-11-04Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONESandoz Inc945d4337-7d18-4d84-807b-8ae13750c76d2024-10-30Warnings, Adverse reactionsName fallback
brand name: Pirfenidone
generic name: PIRFENIDONE
PirfenidonePIRFENIDONETeva Pharmaceuticals, Inc.cbbd14a4-b7e6-4147-9314-bb715dfb1a512024-10-01Warnings, 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.