Topotecan Hydrochloride

ANDA 91199, held by Teyro Labs. Topotecan Hydrochloride.

As of Nov 15, 2026, ANDA 91199 (Topotecan Hydrochloride), held by Teyro Labs, was first approved by FDA on Dec 1, 2010, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 1, 2010
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
Dec 1, 2010	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 5 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Sep 26, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Feb 16, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Dec 1, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91199
Drugs@FDA: Overview at FDA
Company: Teyro Labs

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