Details for New Drug Application (NDA): 065396
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The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Nineteen suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.
Summary for 065396
Tradename: | CEFADROXIL |
Applicant: | Lupin |
Ingredient: | cefadroxil/cefadroxil hemihydrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 065396
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFADROXIL | cefadroxil/cefadroxil hemihydrate | FOR SUSPENSION;ORAL | 065396 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-181 | 68180-181-02 | 100 mL in 1 BOTTLE (68180-181-02) |
CEFADROXIL | cefadroxil/cefadroxil hemihydrate | FOR SUSPENSION;ORAL | 065396 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-182 | 68180-182-02 | 75 mL in 1 BOTTLE (68180-182-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
Approval Date: | Feb 21, 2008 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 500MG BASE/5ML | ||||
Approval Date: | Feb 21, 2008 | TE: | AB | RLD: | No |
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