Details for New Drug Application (NDA): 065276
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NDA 065276 describes CEFPROZIL, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Chartwell Rx, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Teva, and Wockhardt, and is included in fifteen NDAs. It is available from six suppliers. Additional details are available on the CEFPROZIL profile page.
The generic ingredient in CEFPROZIL is cefprozil. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefprozil profile page.
The generic ingredient in CEFPROZIL is cefprozil. There are thirteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the cefprozil profile page.
Summary for 065276
| Tradename: | CEFPROZIL |
| Applicant: | Lupin |
| Ingredient: | cefprozil |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065276
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFPROZIL | cefprozil | TABLET;ORAL | 065276 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-403 | 68180-403-01 | 100 TABLET in 1 BOTTLE (68180-403-01) |
| CEFPROZIL | cefprozil | TABLET;ORAL | 065276 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-404 | 68180-404-01 | 50 TABLET in 1 BOTTLE (68180-404-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Dec 8, 2005 | TE: | AB | RLD: | No | ||||
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