Details for New Drug Application (NDA): 212570
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NDA 212570 describes PIRFENIDONE, which is a drug marketed by Accord Hlthcare, Amneal, Apotex, Aurobindo Pharma, Chartwell Rx, Laurus, Macleods Pharms Ltd, Sandoz, Sciegen Pharms, Aizant, Alembic, Hetero Labs Ltd V, Micro Labs, MSN, and Teva Pharms Usa, and is included in twenty-three 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.
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 212570
| Tradename: | PIRFENIDONE |
| Applicant: | Amneal |
| Ingredient: | pirfenidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212570
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIRFENIDONE | pirfenidone | TABLET;ORAL | 212570 | ANDA | AvKARE | 42291-491 | 42291-491-27 | 3 BOTTLE in 1 CARTON (42291-491-27) / 90 TABLET, FILM COATED in 1 BOTTLE (42291-491-09) |
| PIRFENIDONE | pirfenidone | TABLET;ORAL | 212570 | ANDA | AvKARE | 42291-492 | 42291-492-09 | 1 BOTTLE in 1 CARTON (42291-492-09) / 90 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 267MG | ||||
| Approval Date: | Mar 25, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 801MG | ||||
| Approval Date: | Mar 25, 2022 | TE: | AB | RLD: | No | ||||
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