NDA 22453, held by Meitheal. Topotecan Hydrochloride.
As of Nov 15, 2026, NDA 22453 (Topotecan Hydrochloride), held by Meitheal, was first approved by FDA on Dec 20, 2012, with 10 approved supplements and 0 published complete response letters.
| Sep 20, 2017 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2012 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topotecan HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · solution;intravenous | Topotecan Hydrochloride | Discontinued |
| Jun 24, 2019 | Supplement 11Labeling · Standard review | Approved | |
| Sep 20, 2017 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Nov 14, 2016 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 29, 2016 | Supplement 7Labeling · Standard review | Approved | |
| Dec 21, 2015 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Mar 30, 2015 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 23, 2015 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Sep 23, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 28, 2014 | Supplement 2Labeling · Standard review | Approved | |
| Oct 3, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 20, 2012 | Original applicationNew formulation or manufacturer · Standard review | 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
