Details for New Drug Application (NDA): 065349
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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 065349
Tradename: | CEFADROXIL |
Applicant: | Aurobindo |
Ingredient: | cefadroxil/cefadroxil hemihydrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 065349
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CEFADROXIL | cefadroxil/cefadroxil hemihydrate | FOR SUSPENSION;ORAL | 065349 | ANDA | NorthStar Rx LLC | 16714-389 | 16714-389-01 | 100 mL in 1 BOTTLE (16714-389-01) |
CEFADROXIL | cefadroxil/cefadroxil hemihydrate | FOR SUSPENSION;ORAL | 065349 | ANDA | NorthStar Rx LLC | 16714-390 | 16714-390-01 | 75 mL in 1 BOTTLE (16714-390-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
Approval Date: | Apr 25, 2013 | 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: | Apr 25, 2013 | TE: | AB | RLD: | No |
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