Topotecan Hydrochloride

ANDA 206962, held by Ingenus Pharms LLC. Topotecan Hydrochloride.

As of Nov 15, 2026, ANDA 206962 (Topotecan Hydrochloride), held by Ingenus Pharms LLC, was first approved by FDA on Nov 30, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 30, 2016
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 30, 2016	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 2 submissions, including labeling and manufacturing supplements


Feb 23, 2024	Supplement 1Labeling · Standard review	Approved	None posted
Nov 30, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 206962
Drugs@FDA: Overview at FDA
Company: Ingenus 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