Details for New Drug Application (NDA): 065352
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NDA 065352 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 065352
| Tradename: | CEFADROXIL |
| Applicant: | Aurobindo Pharma |
| Ingredient: | cefadroxil/cefadroxil hemihydrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 065352
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CEFADROXIL | cefadroxil/cefadroxil hemihydrate | CAPSULE;ORAL | 065352 | ANDA | NorthStar Rx LLC | 16714-388 | 16714-388-01 | 50 CAPSULE in 1 BOTTLE (16714-388-01) |
| CEFADROXIL | cefadroxil/cefadroxil hemihydrate | CAPSULE;ORAL | 065352 | ANDA | NorthStar Rx LLC | 16714-388 | 16714-388-02 | 100 CAPSULE in 1 BOTTLE (16714-388-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 500MG BASE | ||||
| Approval Date: | Jan 25, 2007 | TE: | AB | RLD: | No | ||||
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