NDA 200199, held by Sandoz Inc. Topotecan Hydrochloride.
As of Nov 13, 2026, NDA 200199 (Topotecan), held by Sandoz Inc, was first approved by FDA on Feb 25, 2011, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 25, 2011 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TopotecanEQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Topotecan Hydrochloride | DiscontinuedReference drug |
| TopotecanEQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Topotecan Hydrochloride | DiscontinuedReference drug |
| TopotecanEQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;intravenous | Topotecan Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2014 | Supplement 3Labeling · Standard review | Approved | |
| Feb 25, 2011 | 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
