FDA Approval Activities for this Drug…

Cisplatin Injection, 1 mg/mL, 50 mL/vial & 100 mL/vial, Bedford ANDA 75-036 11/7/00 11/16/00 1/8/02 Cisplatin Injection,1 mg/mL, 50 mL/vial & 100 mL/vial. (tentatively Approved 12/29/98) Bedford ANDA 75-036 12/29/98 12/29 Cisplatin Injection,1 mg/mL, Gensia Sicor ANDA 74-814 5/16/00 5/22/00 Cisplatin Injection,1 mg/mL American Pharmaceutical Partners, ANDA 74-735 7/16/99 7/29/99 Cisplatin Injection,10 mg/vial & 50 mg/vial, Bedford Labs ANDA 74-713 11/14/99 11/17/00 Cisplatin Injection,1 mg/mL, Pharmachemie B.V. ANDA 74-656 Platinol (cisplatin for injection, USP) and Platinol-AQ (cisplatin injection). Bristol-Myers Squibb Company 18-057/S-076 Cisplatin Injection, Bedford Laboratories

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