Details for New Drug Application (NDA): 065208
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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.
Suppliers and Packaging for NDA: 065208
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFPROZIL | cefprozil | TABLET;ORAL | 065208 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1077 | 0093-1077-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-1077-01) |
CEFPROZIL | cefprozil | TABLET;ORAL | 065208 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1078 | 0093-1078-53 | 50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Dec 6, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Dec 6, 2005 | TE: | AB | RLD: | No |
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