Details for New Drug Application (NDA): 065261
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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 065261
Tradename: | CEFPROZIL |
Applicant: | Lupin |
Ingredient: | cefprozil |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 065261
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFPROZIL | cefprozil | FOR SUSPENSION;ORAL | 065261 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-401 | 68180-401-01 | 50 mL in 1 BOTTLE (68180-401-01) |
CEFPROZIL | cefprozil | FOR SUSPENSION;ORAL | 065261 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-401 | 68180-401-02 | 75 mL in 1 BOTTLE (68180-401-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML | ||||
Approval Date: | Dec 19, 2005 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML | ||||
Approval Date: | Dec 19, 2005 | TE: | AB | RLD: | No |
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