ANDA 201166, held by Meitheal. Topotecan Hydrochloride.
As of Nov 15, 2026, ANDA 201166 (Topotecan Hydrochloride), held by Meitheal, was first approved by FDA on Aug 8, 2012, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topotecan HydrochlorideEQ 4MG BASE/VIAL · injectable;injection | Topotecan Hydrochloride | Discontinued |
| Jan 28, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 28, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Aug 8, 2012 | 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
