Treats metastatic ovarian cancer after disease progression on or after initial or…. ANDA 90620, held by Actavis Totowa. Topotecan Hydrochloride.
As of Nov 15, 2026, ANDA 90620 (Topotecan Hydrochloride), held by Actavis Totowa, was first approved by FDA on Dec 2, 2010, with 7 approved supplements and 0 published complete response letters.
Topotecan hydrochloride for injection is a topoisomerase inhibitor indicated for treatment of: Patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy, as a single agent Patients with small cell lung cancer (SCLC) platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy, as a single agent Patients with Stage IV-B, recurrent, or persistent cervical cancer which is not amenable to curative treatment, in combination with cisplatin 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 2, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topotecan HydrochlorideEQ 4MG BASE/VIAL · injectable;injection | Topotecan Hydrochloride | Rx |
| Jan 13, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 13, 2020 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 28, 2015 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 28, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 28, 2015 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 30, 2013 | Supplement 4Labeling | Approved | None posted |
| Feb 8, 2011 | Supplement 1Labeling | Approved | None posted |
| Dec 2, 2010 | 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
