Details for New Drug Application (NDA): 081319
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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 081319
Tradename: | PYRAZINAMIDE |
Applicant: | Hikma |
Ingredient: | pyrazinamide |
Patents: | 0 |
Suppliers and Packaging for NDA: 081319
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 081319 | ANDA | Hikma Pharmaceuticals USA Inc | 0054-0812 | 0054-0812-21 | 60 TABLET in 1 CONTAINER (0054-0812-21) |
PYRAZINAMIDE | pyrazinamide | TABLET;ORAL | 081319 | ANDA | Hikma Pharmaceuticals USA Inc | 0054-0812 | 0054-0812-22 | 90 TABLET in 1 CONTAINER (0054-0812-22) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 30, 1992 | TE: | AB | RLD: | No |
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