ANDA 77861, held by Teyro Labs. Carboplatin.
As of Nov 15, 2026, ANDA 77861 (Carboplatin), held by Teyro Labs, was first approved by FDA on Jan 18, 2007, 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 |
|---|---|---|---|
| Jan 18, 2007 | 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 |
| Jun 16, 2023 | Supplement 2Manufacturing | Approved | None posted |
| Mar 5, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 18, 2007 | Original application | Approved | None posted |
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
