ANDA 202203, held by Sun Pharm Inds Ltd. Topotecan Hydrochloride.
As of Nov 15, 2026, ANDA 202203 (Topotecan Hydrochloride), held by Sun Pharm Inds Ltd, was first approved by FDA on Aug 29, 2013, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topotecan HydrochlorideEQ 4MG BASE/VIAL · injectable;injection | Topotecan Hydrochloride | Discontinued |
| Dec 16, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Dec 16, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 29, 2013 | Original application | Approved | None posted |
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
