You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 16, 2025

Details for New Drug Application (NDA): 212708

✉ Email this page to a colleague

« Back to Dashboard

NDA 212708 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 212708

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

Pharmacology for NDA: 212708

Suppliers and Packaging for NDA: 212708

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PIRFENIDONE	pirfenidone	TABLET;ORAL	212708	ANDA	Alembic Pharmaceuticals Limited	46708-479	46708-479-27	270 TABLET, COATED in 1 BOTTLE (46708-479-27)
PIRFENIDONE	pirfenidone	TABLET;ORAL	212708	ANDA	Alembic Pharmaceuticals Limited	46708-479	46708-479-64	3 BOTTLE in 1 CARTON (46708-479-64) / 90 TABLET, COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	267MG
Approval Date:	May 20, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	801MG
Approval Date:	May 20, 2022	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.