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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 212722


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NDA 212722 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 212722
Tradename:PIRFENIDONE
Applicant:Laurus
Ingredient:pirfenidone
Patents:0
Pharmacology for NDA: 212722
Suppliers and Packaging for NDA: 212722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIRFENIDONE pirfenidone TABLET;ORAL 212722 ANDA Laurus Labs Limited 42385-924 42385-924-99 3 BOTTLE in 1 CARTON (42385-924-99) / 90 TABLET, FILM COATED in 1 BOTTLE
PIRFENIDONE pirfenidone TABLET;ORAL 212722 ANDA Laurus Labs Limited 42385-925 42385-925-90 90 TABLET, FILM COATED in 1 BOTTLE (42385-925-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength267MG
Approval Date:Jul 19, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength534MG
Approval Date:Jul 19, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength801MG
Approval Date:Jul 19, 2022TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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