Details for New Drug Application (NDA): 212730
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NDA 212730 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 212730
| Tradename: | PIRFENIDONE |
| Applicant: | Accord Hlthcare |
| Ingredient: | pirfenidone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212730
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIRFENIDONE | pirfenidone | TABLET;ORAL | 212730 | ANDA | Accord Healthcare Inc. | 16729-467 | 16729-467-85 | 3 BOTTLE, PLASTIC in 1 CARTON (16729-467-85) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-467-15) |
| PIRFENIDONE | pirfenidone | TABLET;ORAL | 212730 | ANDA | Accord Healthcare Inc. | 16729-468 | 16729-468-15 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16729-468-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 267MG | ||||
| Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 801MG | ||||
| Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No | ||||
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