Details for New Drug Application (NDA): 065349
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NDA 065349 describes CEFADROXIL, which is a drug marketed by Aurobindo Pharma, Chartwell Rx, Cspc Ouyi, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Ranbaxy Labs Ltd, Sandoz, Teva, Teva Pharms, Ani Pharms, Apothecon, Aurobindo, Hikma Pharms, Sun Pharm Inds Ltd, and Ranbaxy, and is included in twenty-three NDAs. It is available from nineteen suppliers. Additional details are available on the CEFADROXIL profile page.
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.
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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