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… Carboplatin Injection USP, 50, 150 and 450 mg, Faulding Pharmaceutical ANDA 76-473 4/16/03 Carboplatin Injection USP, 50, 150 or 450 mg, American Pharmaceutical Partners, ANDA 76-235 5/22/02 Carboplatin Injection USP, 10 mgmL, Gensia Sicor ANDA 76-227 8/12/02 Carboplatin Injection USP, 50, 150 or 450 mg, Pharmachemie B.V. ANDA 76-162 1/14/03 Carboplatin Injection USP, 10 mg/mL, Bedford ANDA 76-039 6/6/03 Carboplatin Injection USP, 50, 150 & 450 mg, Bedford ANDA 76-099 Paraplatin (Carboplatin Aqueous) Solution Injection, Bristol-Myers Squibb Co. NDA 20-452 7/14/03 7/28/03 Paraplatin (Carboplatin) Injection Bristol-Myers Squibb NDA 19880/S011 2/14/02 3/8/02 Paraplatin (Carboplatin) Injection Bristol-Myers Squibb NDA 19880/S009 Paraplatin (Carboplatin Aqueous Solution) Injection, Bristol-Myers Squibb Co. Carboplatin Injection USP, Mayne Pharma,   For the latest approval information, locate this drug using this index.