Topotecan Hydrochloride

ANDA 91542, held by Rising. Topotecan Hydrochloride.

As of Nov 15, 2026, ANDA 91542 (Topotecan Hydrochloride), held by Rising, was first approved by FDA on Aug 28, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2012
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Aug 28, 2012	Original application	Approved	None posted

Products

1 strengths and forms

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

All 5 submissions, including labeling and manufacturing supplements


Mar 19, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Mar 19, 2021	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 3, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Dec 3, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Aug 28, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 91542
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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