Last Updated: November 14, 2026

Details for New Drug Application (NDA): 212404

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NDA 212404 describes PIRFENIDONE, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms, Sandoz, Sciegen Pharms, Aizant, Alembic, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa, and is included in twenty-three NDAs. It is available from twenty-three suppliers. Additional details are available on the PIRFENIDONE profile page.

The generic ingredient in PIRFENIDONE is pirfenidone. There is one drug master file entry for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.

Summary for 212404

Tradename:	PIRFENIDONE
Applicant:	Chartwell Rx
Ingredient:	pirfenidone
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	267MG
Approval Date:	Aug 28, 2023	TE:		RLD:	No

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