FDA Approval Activities for this Drug…

Cefadroxil Capsules USP, 500 mg (base) Barr ANDA 65-015 6/22/99 6/22/99 Cefadroxil for Suspension USP Powder, 125 mg/5 mL, 250 mg/5 mL, and 500 mg/5 mL, Ranbaxy ANDA 65-115 3/26/03 Cefadroxil Tablets USP, 1 g base Ranbaxy ANDA 65-018 Duricef® (cefadroxil monohydrate, USP) Capsules, Suspension & Tablets, Bristol-Myers Squibb Company NDA 50-512/S-044, 50-527/S-020 & 50-528/S-018 CEFADROXIL/CEFADROXIL HEMIHYDRATE Capsule; 500MG BASE CEFADROXIL APOTHECON 065015 CEFADROXIL/CEFADROXIL HEMIHYDRATE Capsule; 500MG BASE CEFADROXIL Barr 062766 CEFADROXIL/CEFADROXIL HEMIHYDRATE Capsule; 500MG BASE CEFADROXIL Ivax 050512 CEFADROXIL/CEFADROXIL HEMIHYDRATE Capsule; 500MG BASE DURICEF WARNER CHILCOTT 065115 CEFADROXIL/CEFADROXIL HEMIHYDRATE For Suspension; 125MG BASE/5ML CEFADROXIL Ranbaxy 065115 CEFADROXIL/CEFADROXIL HEMIHYDRATE For Suspension; 250MG BASE/5ML CEFADROXIL Ranbaxy 065115 CEFADROXIL/CEFADROXIL HEMIHYDRATE For Suspension; 500MG BASE/5ML CEFADROXIL Ranbaxy 050527 CEFADROXIL/CEFADROXIL HEMIHYDRATE For Suspension; 125MG BASE/5ML DURICEF WARNER CHILCOTT 050527 CEFADROXIL/CEFADROXIL HEMIHYDRATE For Suspension; 250MG BASE/5ML DURICEF WARNER CHILCOTT 050527 CEFADROXIL/CEFADROXIL HEMIHYDRATE For Suspension; 500MG BASE/5ML DURICEF WARNER CHILCOTT 065018 CEFADROXIL/CEFADROXIL HEMIHYDRATE Tablet; 1GM BASE CEFADROXIL Ranbaxy 050528 CEFADROXIL/CEFADROXIL HEMIHYDRATE Tablet; 1GM BASE DURICEF WARNER CHILCOTT Duricef (cefadroxil monohydrate, USP) Capsules, Oral Suspension & Tablets, Bristol-Myers Squibb Company

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