 |
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 | Platinol (cisplatin) Injection, Bristol-Myers Squibb Co., Labeling Revision | Platinol-AQ (cisplatin) Injection, Bristol-Myers Squibb Co., Labeling Revision | Platinol (cisplatin) injection, Bristol Myers, Labeling Revision | Platinol, cisplatin, Injectable; Injection, Corden Pharma, Labeling Revision | Platinol-Aq, cisplatin, Injectable; Injection, Corden Pharma, Labeling Revision
View updates.
|