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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 212772


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NDA 212772 describes PIRFENIDONE, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Laurus, Lupin Ltd, Sandoz, Sciegen Pharms Inc, Aizant, Alembic, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa, and is included in twenty NDAs. It is available from seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 212772
Tradename:PIRFENIDONE
Applicant:Msn
Ingredient:pirfenidone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212772
Suppliers and Packaging for NDA: 212772
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIRFENIDONE pirfenidone TABLET;ORAL 212772 ANDA MAJOR PHARMACEUTICALS 0904-7397 0904-7397-53 3 BOTTLE in 1 CARTON (0904-7397-53) / 90 TABLET, FILM COATED in 1 BOTTLE (0904-7397-89)
PIRFENIDONE pirfenidone TABLET;ORAL 212772 ANDA MAJOR PHARMACEUTICALS 0904-7398 0904-7398-89 90 TABLET, FILM COATED in 1 BOTTLE (0904-7398-89)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength267MG
Approval Date:May 24, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength801MG
Approval Date:May 24, 2022TE:ABRLD:No

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