Treats metastatic ovarian cancer after disease progression on or after initial or…. ANDA 202351, held by Accord Hlthcare. Topotecan Hydrochloride.
As of Nov 15, 2026, ANDA 202351 (Topotecan Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Jun 26, 2013, with 3 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 |
|---|---|---|---|
| Jun 26, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Topotecan HydrochlorideEQ 4MG BASE/VIAL · injectable;injection | Topotecan Hydrochloride | Rx |
| Aug 20, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 17, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 17, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 26, 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
