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FDA Approval Activities for this Drug…

Ceclor (Cefaclor) Pulvules & Suspension, Eli Lilly Company NDA 50-521/S-26 & 50-522/S-24 3/3/03 3/10/03 Ceclor (Cefaclor) Pulvules & Suspension Lilly Research NDA 50-521/S-021 & 50-522/S-018 Cefaclor Capsules USP, 250 mg & 500 mg Biocraft AADA 64-081 9/16/98 8/23/01 Cefaclor Extended-release Tablets, USP, 375 & 500mg, Teva ANDA 65-058 9/4/02 Cefaclor Extended-release Tablets, USP, 500mg, Zenith Goldline ANDA 65-057 1/5/01 Cefaclor for Suspension, USP, 125mg, 187mg, 250mg, and 375mg (base/5mL) Marsam ANDA 64-204, 64-205, 64-206, 64-207 CEFACLOR Capsule; 250MG BASE CECLOR CEPH INTL 062205 CEFACLOR Capsule; 500MG BASE CECLOR CEPH INTL 064061 CEFACLOR Capsule; 250MG BASE CEFACLOR Ivax 064061 CEFACLOR Capsule; 500MG BASE CEFACLOR Ivax 050521 CEFACLOR Capsule; 250MG BASE CECLOR LILLY 050521 CEFACLOR Capsule; 500MG BASE CECLOR LILLY 064148 CEFACLOR Capsule; 250MG BASE CEFACLOR MARSAM 064148 CEFACLOR Capsule; 500MG BASE CEFACLOR MARSAM 064156 CEFACLOR Capsule; 250MG BASE CEFACLOR Ranbaxy 064156 CEFACLOR Capsule; 500MG BASE CEFACLOR Ranbaxy 064145 CEFACLOR Capsule; 250MG BASE CEFACLOR Teva 064145 CEFACLOR Capsule; 500MG BASE CEFACLOR Teva 064070 CEFACLOR For Suspension; 375MG BASE/5ML CEFACLOR Ivax 050522 CEFACLOR For Suspension; 125MG BASE/5ML CECLOR LILLY 062206 CEFACLOR For Suspension; 125MG BASE/5ML CECLOR LILLY 062206 CEFACLOR For Suspension; 187MG BASE/5ML CECLOR LILLY 062206 CEFACLOR For Suspension; 250MG BASE/5ML CECLOR LILLY 050522 CEFACLOR For Suspension; 250MG BASE/5ML CECLOR LILLY 062206 CEFACLOR For Suspension; 375MG BASE/5ML CECLOR LILLY 064204 CEFACLOR For Suspension; 125MG BASE/5ML CEFACLOR MARSAM 064205 CEFACLOR For Suspension; 187MG BASE/5ML CEFACLOR MARSAM 064206 CEFACLOR For Suspension; 250MG BASE/5ML CEFACLOR MARSAM 064207 CEFACLOR For Suspension; 375MG BASE/5ML CEFACLOR MARSAM 064166 CEFACLOR For Suspension; 125MG BASE/5ML CEFACLOR Ranbaxy 064165 CEFACLOR For Suspension; 187MG BASE/5ML CEFACLOR Ranbaxy 064164 CEFACLOR For Suspension; 250MG BASE/5ML CEFACLOR Ranbaxy 064155 CEFACLOR For Suspension; 375MG BASE/5ML CEFACLOR Ranbaxy 065057 CEFACLOR Tablet, Extended Release; 500MG BASE CEFACLOR Ivax 050673 CEFACLOR Tablet, Extended Release; 500MG BASE CECLOR CD LILLY 065058 CEFACLOR Tablet, Extended Release; 375MG BASE CEFACLOR Teva 065058 CEFACLOR Tablet, Extended Release; 500MG BASE CEFACLOR Teva Cefaclor Capsules USP, Yung Shin Pharmaceutical Ceclor (Cefaclor) Pulvules & Oral Suspension, Eli Lilly Company

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