ANDA 91376, held by Fresenius Kabi USA. Topotecan Hydrochloride.
As of Nov 15, 2026, ANDA 91376 (Topotecan Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Nov 29, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2010 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topotecan HydrochlorideEQ 4MG BASE/VIAL ยท injectable;injection | Topotecan Hydrochloride | 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
