Details for New Drug Application (NDA): 091036
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NDA 091036 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 twenty-two suppliers. Additional details are available on the CEFADROXIL profile page.
The generic ingredient in CEFADROXIL is cefadroxil/cefadroxil hemihydrate. Twenty-two 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. Twenty-two suppliers are listed for this compound. Additional details are available on the cefadroxil/cefadroxil hemihydrate profile page.
Summary for 091036
| Tradename: | CEFADROXIL |
| Applicant: | Hikma Pharms |
| Ingredient: | cefadroxil/cefadroxil hemihydrate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 250MG BASE/5ML | ||||
| Approval Date: | Nov 28, 2012 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 500MG BASE/5ML | ||||
| Approval Date: | Nov 28, 2012 | TE: | RLD: | No | |||||
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