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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 212772

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NDA 212772 describes PIRFENIDONE, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Chartwell Rx, Laurus, Macleods Pharms Ltd, Sandoz, Sciegen Pharms Inc, Aizant, Alembic, Aurobindo Pharma, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from twenty-two suppliers. Additional details are available on the PIRFENIDONE profile page.

The generic ingredient in PIRFENIDONE is pirfenidone. There are twenty-three drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.

Summary for 212772

Tradename:	PIRFENIDONE
Applicant:	Msn
Ingredient:	pirfenidone
Patents:	0

Pharmacology for NDA: 212772

Suppliers and Packaging for NDA: 212772

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PIRFENIDONE	pirfenidone	TABLET;ORAL	212772	ANDA	MAJOR PHARMACEUTICALS	0904-7397	0904-7397-53	3 BOTTLE in 1 CARTON (0904-7397-53) / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89)
PIRFENIDONE	pirfenidone	TABLET;ORAL	212772	ANDA	MAJOR PHARMACEUTICALS	0904-7398	0904-7398-89	90 TABLET, FILM COATED in 1 BOTTLE (0904-7398-89)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	267MG
Approval Date:	May 24, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	801MG
Approval Date:	May 24, 2022	TE:	AB	RLD:	No

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