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, | Carboplatin Injection, Bedford Labs, Approval | Carboplatin Injection, Mayne Pharma, Approval | Carboplatin Injection, Pharmachemie, Approval | Carboplatin Injection, American Pharmaceutical Partners, Approval | Carboplatin Injection, Bedford Labs, Approval | Carboplatin Injection, American Pharmaceutical, Approval | Carboplatin Injection, Mayne Pharma, Approval | Carboplatin Injection, Pliva-Lachema, Approval | Carboplatin Injection, Eon Labs, Approval

For the latest approval information, please see the main page.