Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Cefotaxime Injection USP, 500 mg, Lupin Limited ANDA 65-124 9/24/03 Cefotaxime Injection USP, 500 mg, 1 g, & 2 g vials, and 1 & 2 g infusion bottles, Hikma Farmaceutica (Portugal) Lta. ANDA 65-072 11/20/02 Cefotaxime Injection USP, 10 g Pharmacy Bulk Package, Hikma Farmaceutica (Portugal) Lta. ANDA 65-071 11/20/02 Cefotaxime Injection USP, 1 g, & 2 g vials, American Pharmaceutical Partners, ANDA 64-200 3/24/00 3/31/00 Cefotaxime Injection USP,10 g, & 20 g vials, American Pharmaceutical Partners, ANDA 64-201 Claforan (cefotaxime sodium) Injection and Sterile Solution Aventis NDA 50-547/S-047 & 50-596/S-023 CEFOTAXIME SODIUM Injection 10GM BASE/VIAL CEFOTAXIME AM PARTNERS 064200 CEFOTAXIME SODIUM Injection 1GM BASE/VIAL CEFOTAXIME AM PARTNERS 064201 CEFOTAXIME SODIUM Injection 20GM BASE/VIAL CEFOTAXIME AM PARTNERS 064200 CEFOTAXIME SODIUM Injection 2GM BASE/VIAL CEFOTAXIME AM PARTNERS 064200 CEFOTAXIME SODIUM Injection 500MG BASE/VIAL CEFOTAXIME AM PARTNERS 050547 CEFOTAXIME SODIUM Injection 10GM BASE/VIAL CLAFORAN AVENTIS 062659 CEFOTAXIME SODIUM Injection 1GM BASE/VIAL CLAFORAN AVENTIS 050547 CEFOTAXIME SODIUM Injection 1GM BASE/VIAL CLAFORAN AVENTIS 050596 CEFOTAXIME SODIUM Injection 20MG BASE/ML CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER AVENTIS 050596 CEFOTAXIME SODIUM Injection 20MG BASE/ML CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER AVENTIS 050547 CEFOTAXIME SODIUM Injection 2GM BASE/VIAL CLAFORAN AVENTIS 062659 CEFOTAXIME SODIUM Injection 2GM BASE/VIAL CLAFORAN AVENTIS 050596 CEFOTAXIME SODIUM Injection 40MG BASE/ML CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER AVENTIS 050596 CEFOTAXIME SODIUM Injection 40MG BASE/ML CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER AVENTIS 050547 CEFOTAXIME SODIUM Injection 500MG BASE/VIAL CLAFORAN AVENTIS 065071 CEFOTAXIME SODIUM Injection 10GM BASE/VIAL CEFOTAXIME Hikma 065072 CEFOTAXIME SODIUM Injection 1GM BASE/VIAL CEFOTAXIME Hikma 065072 CEFOTAXIME SODIUM Injection 2GM BASE/VIAL CEFOTAXIME Hikma 065072 CEFOTAXIME SODIUM Injection 500MG BASE/VIAL CEFOTAXIME Hikma 065124 CEFOTAXIME SODIUM Injection 1GM BASE/VIAL CEFOTAXIME SODIUM Lupin 065124 CEFOTAXIME SODIUM Injection 2GM BASE/VIAL CEFOTAXIME SODIUM Lupin 065124 CEFOTAXIME SODIUM Injection 500MG BASE/VIAL CEFOTAXIME SODIUM Lupin Claforan (cefotaxime sodium) Injection, Aventis Pharmaceuticals Inc. | Claforan (cefotaxime sodium) Sterile, Aventis Pharmaceuticals Inc. | Cefotaxime and Dextrose Injection, B. Braun, Approval | Claforan Sterile (Cefotaxime sodium, USP), Aventis, Labeling Revision | Claforan (cefotaxime sodium, USP) for injection, Aventis, Labeling Revision | Claforan (cefotaxime sterile) IV or IM, Aventis, Labeling Revision | Cefotaxime Injection, Orchid Healthcare, Approval | Cefotaxime Injection, Orchid Healthcare, Approval | Cefotaxime Injection, Wockhardt, Approval | Cefotaxime Injection and Dextrose Injection, B. Braun Medical, Inc., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com