Last Updated: May 10, 2026

Details for New Drug Application (NDA): 212687

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NDA 212687 describes PIRFENIDONE, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Chartwell Rx, Laurus, Macleods Pharms Ltd, Sandoz, Sciegen Pharms, 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 212687

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	267MG
Approval Date:	Jun 9, 2023	TE:		RLD:	No

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