Details for New Drug Application (NDA): 065381
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NDA 065381 describes CEFPROZIL, which is a drug marketed by Apotex Inc, Aurobindo Pharma, Chartwell Rx, Lupin, Orchid Hlthcare, Ranbaxy Labs Ltd, Sandoz, Alkem Labs Ltd, Teva, and Wockhardt, and is included in sixteen NDAs. It is available from seven 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the cefprozil profile page.
Summary for 065381
| Tradename: | CEFPROZIL |
| Applicant: | Aurobindo Pharma |
| Ingredient: | cefprozil |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065381
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFPROZIL | cefprozil | FOR SUSPENSION;ORAL | 065381 | ANDA | NorthStar Rx LLC | 16714-396 | 16714-396-02 | 75 mL in 1 BOTTLE (16714-396-02) |
| CEFPROZIL | cefprozil | FOR SUSPENSION;ORAL | 065381 | ANDA | NorthStar Rx LLC | 16714-396 | 16714-396-03 | 100 mL in 1 BOTTLE (16714-396-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
| Approval Date: | Jan 30, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
| Approval Date: | Jan 30, 2007 | TE: | AB | RLD: | No | ||||
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