ANDA 77269, held by Pharmachemie BV. Carboplatin.
As of Nov 15, 2026, ANDA 77269 (Carboplatin), held by Pharmachemie BV, was first approved by FDA on Oct 14, 2004, with 2 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 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 |
|---|---|---|---|
| Oct 14, 2004 | Original application | Approved |
| Carboplatin50MG/5ML (10MG/ML) · injectable;intravenous | Carboplatin | Rx |
| Carboplatin150MG/15ML (10MG/ML) · injectable;intravenous | Carboplatin | Rx |
| Carboplatin450MG/45ML (10MG/ML) · injectable;intravenous | Carboplatin | Rx |
| Carboplatin600MG/60ML (10MG/ML) · injectable;intravenous | Carboplatin | Rx |
| Mar 26, 2012 | Supplement 8Labeling | Approved | None posted |
| Dec 28, 2007 | Supplement 2Labeling | Approved | None posted |
| Oct 14, 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
