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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212747

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NDA 212747 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 212747

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	267MG
Approval Date:	Jul 21, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	534MG
Approval Date:	Jul 21, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	801MG
Approval Date:	Jul 21, 2022	TE:	AB	RLD:	No

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