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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 212724


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NDA 212724 describes PIRFENIDONE, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Chartwell Rx, Laurus, 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 twenty 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-one suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 212724
Tradename:PIRFENIDONE
Applicant:Laurus
Ingredient:pirfenidone
Patents:0
Pharmacology for NDA: 212724
Suppliers and Packaging for NDA: 212724
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIRFENIDONE pirfenidone CAPSULE;ORAL 212724 ANDA Laurus Labs Limited 42385-923 42385-923-29 270 CAPSULE in 1 BOTTLE (42385-923-29)
PIRFENIDONE pirfenidone CAPSULE;ORAL 212724 ANDA Laurus Labs Limited 42385-923 42385-923-54 4 BLISTER PACK in 1 CARTON (42385-923-54) / 63 CAPSULE in 1 BLISTER PACK

Profile for product number 001

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

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