Details for New Drug Application (NDA): 080157
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NDA 080157 describes PYRAZINAMIDE, which is a drug marketed by Hikma, Macleods Pharms Ltd, and Novitium Pharma, and is included in three NDAs. It is available from eight suppliers. Additional details are available on the PYRAZINAMIDE profile page.
The generic ingredient in PYRAZINAMIDE is pyrazinamide. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the pyrazinamide profile page.
The generic ingredient in PYRAZINAMIDE is pyrazinamide. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the pyrazinamide profile page.
Summary for 080157
| Tradename: | PYRAZINAMIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | pyrazinamide |
| Patents: | 0 |
Suppliers and Packaging for NDA: 080157
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 080157 | ANDA | MARLEX PHARMACEUTICALS, INC | 10135-735 | 10135-735-01 | 100 TABLET in 1 BOTTLE (10135-735-01) |
| PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 080157 | ANDA | MARLEX PHARMACEUTICALS, INC | 10135-735 | 10135-735-60 | 60 TABLET in 1 BOTTLE (10135-735-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
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