Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.