Topotecan Hydrochloride

ANDA 201191, held by Dr Reddys Labs Ltd. Topotecan Hydrochloride.

As of Nov 15, 2026, ANDA 201191 (Topotecan Hydrochloride), held by Dr Reddys Labs Ltd, was first approved by FDA on Mar 9, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 9, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Mar 9, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 3 submissions, including labeling and manufacturing supplements


Dec 11, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Dec 11, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Mar 9, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201191
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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