ANDA 77059, held by Hospira. Carboplatin.
As of Nov 15, 2026, ANDA 77059 (Carboplatin), held by Hospira, was first approved by FDA on Nov 23, 2004, with 3 approved supplements and 0 published complete response letters.
INDICATIONS Initial Treatment of Advanced Ovarian Carcinoma Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of Carboplatin Injection and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES ).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2004 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Carboplatin600MG/60ML (10MG/ML) · injectable;intravenous | Carboplatin | Rx |
| Jun 7, 2024 | Supplement 24Labeling · Standard review | Approved | None posted |
| Jul 24, 2017 | Supplement 19Manufacturing | Approved | None posted |
| Jun 7, 2005 | Supplement 3Labeling | Approved | None posted |
| Nov 23, 2004 | 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
