Details for New Drug Application (NDA): 212569
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NDA 212569 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.
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 212569
| Tradename: | PIRFENIDONE |
| Applicant: | Amneal |
| Ingredient: | pirfenidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212569
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212569 | ANDA | AvKARE | 42291-490 | 42291-490-27 | 1 BOTTLE in 1 CARTON (42291-490-27) / 270 CAPSULE in 1 BOTTLE |
| PIRFENIDONE | pirfenidone | CAPSULE;ORAL | 212569 | ANDA | Amneal Pharmaceuticals NY LLC | 60219-1642 | 60219-1642-7 | 1 BOTTLE in 1 CARTON (60219-1642-7) / 270 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 267MG | ||||
| Approval Date: | Jan 3, 2022 | TE: | AB | RLD: | No | ||||
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