ANDA 77679, held by Pharmachemie BV. Carboplatin.
As of Nov 15, 2026, ANDA 77679 (Carboplatin), held by Pharmachemie BV, was first approved by FDA on Feb 25, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2009 | 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
