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… Carbamazepine Tablets, 200 mg, Taro ANDA 75-687/S1 7/29/02 Carbamazepine Suspension USP, 100 mg/5 mL, Taro Pharmaceutical Industries Ltd. ANDA 75-875 12/21/00 2/27/01 Carbamazepine Tablets USP, 200 mg, Apotex ANDA 75-948 2/27/02 Carbamazepine Suspension USP, 100 mg/5 mL, Morton Grove ANDA 75-714 6/5/02 Carbamazepine (Chewable) Tablets USP, 100 mg, Caraco Pharmaceutical , Ltd. ANDA 75-712 7/5/01 Carbamazepine (Chewable) Tablets USP, 100 mg, Taro Pharmaceutical Industries Ltd. ANDA 75-687 Tegretol (carbamezepine) Drug Products Novartis NDA 20-234/S-017, 18-927/S-031, 18-281/S-039, 16-608/S-090 Teril (Carbamazepine) Tablets, 200 mg, Taro Pharmaceutical ANDA 76-525 CARBAMAZEPINE Capsule, Extended Release; 100MG CARBATROL SHIRE 020712 CARBAMAZEPINE Capsule, Extended Release; 200MG CARBATROL SHIRE 020712 CARBAMAZEPINE Capsule, Extended Release; 300MG CARBATROL SHIRE 075714 CARBAMAZEPINE Suspension; 100MG/5ML CARBAMAZEPINE Morton Grove 018927 CARBAMAZEPINE Suspension; 100MG/5ML TEGRETOL NOVARTIS 075875 CARBAMAZEPINE Suspension; 100MG/5ML CARBAMAZEPINE Taro 075712 CARBAMAZEPINE Tablet, Chewable; 100MG CARBAMAZEPINE Caraco 018281 CARBAMAZEPINE Tablet, Chewable; 100MG TEGRETOL NOVARTIS 075687 CARBAMAZEPINE Tablet, Chewable; 100MG CARBAMAZEPINE Taro INDS 075687 CARBAMAZEPINE Tablet, Chewable; 200MG CARBAMAZEPINE Taro INDS 073524 CARBAMAZEPINE Tablet, Chewable; 100MG EPITOL Teva 071940 CARBAMAZEPINE Tablet, Chewable; 100MG CARBAMAZEPINE WARNER CHILCOTT 020234 CARBAMAZEPINE Tablet, Extended Release; 100MG TEGRETOL-XR NOVARTIS 020234 CARBAMAZEPINE Tablet, Extended Release; 200MG TEGRETOL-XR NOVARTIS 020234 CARBAMAZEPINE Tablet, Extended Release; 400MG TEGRETOL-XR NOVARTIS 075948 CARBAMAZEPINE Tablet; 200MG CARBAMAZEPINE Apotex 070231 CARBAMAZEPINE Tablet; 200MG CARBAMAZEPINE INWOOD 016608 CARBAMAZEPINE Tablet; 200MG TEGRETOL NOVARTIS 071479 CARBAMAZEPINE Tablet; 200MG CARBAMAZEPINE Pliva 071696 CARBAMAZEPINE Tablet; 200MG CARBAMAZEPINE Purepac 074649 CARBAMAZEPINE Tablet; 200MG CARBAMAZEPINE Taro 076525 CARBAMAZEPINE Tablet; 200MG TERIL Taro 070541 CARBAMAZEPINE Tablet; 200MG EPITOL Teva   For the latest approval information, locate this drug using this index.