ANDA 207324, held by Gland. Carboplatin.
As of Nov 15, 2026, ANDA 207324 (Carboplatin), held by Gland, was first approved by FDA on Feb 15, 2017, with 0 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 |
|---|---|---|---|
| Feb 15, 2017 | Original application | Approved | None posted |
| 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 |
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
