Details for New Drug Application (NDA): 212560
✉ Email this page to a colleague
NDA 212560 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 eighteen 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. Nineteen suppliers are listed for this compound. 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. Nineteen suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 212560
| Tradename: | PIRFENIDONE |
| Applicant: | Sandoz |
| Ingredient: | pirfenidone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 212560
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIRFENIDONE | pirfenidone | TABLET;ORAL | 212560 | ANDA | Sandoz Inc | 0781-8085 | 0781-8085-32 | 270 TABLET, FILM COATED in 1 CARTON (0781-8085-32) |
| PIRFENIDONE | pirfenidone | TABLET;ORAL | 212560 | ANDA | Sandoz Inc | 0781-8086 | 0781-8086-92 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0781-8086-92) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 267MG | ||||
| Approval Date: | Apr 28, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 801MG | ||||
| Approval Date: | Apr 28, 2022 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
