ANDA 77247, held by Fresenius Kabi USA. Carboplatin.
As of Nov 15, 2026, ANDA 77247 (Carboplatin), held by Fresenius Kabi USA, was first approved by FDA on Oct 21, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2004 | Original application | Approved | None posted |
| Carboplatin50MG/5ML (10MG/ML) · injectable;intravenous | Carboplatin | Discontinued |
| Carboplatin150MG/15ML (10MG/ML) · injectable;intravenous | Carboplatin | Discontinued |
| Carboplatin450MG/45ML (10MG/ML) · injectable;intravenous | Carboplatin | Discontinued |
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