Treats advanced testicular cancer. ANDA 74656, held by Pharmachemie BV. Cisplatin.
As of Nov 15, 2026, ANDA 74656 (Cisplatin), held by Pharmachemie BV, was first approved by FDA on May 16, 2000, with 7 approved supplements and 0 published complete response letters.
Cisplatin Injection is a platinum-based drug indicated for the treatment of: Advanced testicular cancer Advanced ovarian cancer Advanced bladder cancer 1.1 Advanced Testicular Cancer Cisplatin Injection is indicated for the treatment of advanced testicular cancer. 1.2 Advanced Ovarian Cancer Cisplatin Injection is indicated for the treatment of advanced ovarian cancer. 1.3 Advanced Bladder Cancer Cisplatin Injection is indicated for the treatment of advanced bladder cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cisplatin1MG/ML · injectable;injection | Cisplatin | Rx |
| Oct 23, 2023 | Supplement 20Labeling · Standard review | Approved | None posted |
| Sep 22, 2015 | Supplement 15Labeling · Standard review | Approved | None posted |
| Mar 15, 2012 | Supplement 12Labeling | Approved | None posted |
| Jan 23, 2012 | Supplement 10Labeling | Approved | None posted |
| Oct 17, 2008 | Supplement 6Labeling | Approved | None posted |
| Jul 17, 2002 | Supplement 1Manufacturing | Approved | None posted |
| Jul 1, 2002 | Supplement 2Manufacturing | Approved | None posted |
| May 16, 2000 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
