ANDA 204406, held by Accord Hlthcare. Topotecan Hydrochloride.
As of Nov 15, 2026, ANDA 204406 (Topotecan Hydrochloride), held by Accord Hlthcare, was first approved by FDA on Jul 6, 2017, with 0 approved supplements and 0 published complete response letters.
Topotecan Injection is indicated for the treatment of: small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy. Topotecan Injection in combination with cisplatin is indicated for the treatment of: stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 6, 2017 | Original application | Approved | None posted |
| Topotecan HydrochlorideEQ 1MG BASE/ML (EQ 1MG BASE/ML) · solution;intravenous | Topotecan Hydrochloride | Rx |
| Topotecan HydrochlorideEQ 4MG BASE/4ML (EQ 1MG BASE/ML) · solution;intravenous | Topotecan Hydrochloride | Rx |
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
