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For metastatic testicular tumors. ANDA 75036, held by Hikma. Cisplatin.
As of Nov 15, 2026, ANDA 75036 (Cisplatin), held by Hikma, was first approved by FDA on Nov 7, 2000, with 7 approved supplements and 0 published complete response letters.
First approved: Nov 7, 2000
Supplements approved: 7
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide.
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
