Topotecan Hydrochloride

Treats metastatic ovarian cancer after disease progression on or after initial or…. ANDA 91089, held by Fresenius Kabi USA. Topotecan Hydrochloride.

As of Nov 15, 2026, ANDA 91089 (Topotecan Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Nov 29, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 29, 2010
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 29, 2010	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Topotecan HydrochlorideEQ 4MG BASE/VIAL · injectable;injection	Topotecan Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Feb 26, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Feb 26, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Nov 29, 2010	Original application	Approved	Letter

Identifiers

Application: ANDA 91089
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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