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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 212680

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NDA 212680 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 212680

Tradename:	PIRFENIDONE
Applicant:	Micro Labs
Ingredient:	pirfenidone
Patents:	0

Pharmacology for NDA: 212680

Suppliers and Packaging for NDA: 212680

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PIRFENIDONE	pirfenidone	TABLET;ORAL	212680	ANDA	Micro Labs Limited	42571-335	42571-335-39	3 TABLET, FILM COATED in 1 CARTON (42571-335-39)
PIRFENIDONE	pirfenidone	TABLET;ORAL	212680	ANDA	Micro Labs Limited	42571-335	42571-335-90	90 BOTTLE in 1 CARTON (42571-335-90) / 90 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	267MG
Approval Date:	May 18, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	801MG
Approval Date:	May 18, 2022	TE:	AB	RLD:	No

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