ANDA 206074, held by Natco Pharma USA. Topotecan Hydrochloride.
As of Nov 15, 2026, ANDA 206074 (Topotecan Hydrochloride), held by Natco Pharma USA, was first approved by FDA on Nov 24, 2017, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 24, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topotecan HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · solution;intravenous | Topotecan Hydrochloride | Discontinued |
| Aug 6, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 24, 2017 | Original application | Approved |
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
