Topotecan Hydrochloride

ANDA 91284, held by Sagent Pharms. Topotecan Hydrochloride.

As of Nov 15, 2026, ANDA 91284 (Topotecan Hydrochloride), held by Sagent Pharms, was first approved by FDA on Jan 26, 2011, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 26, 2011
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
Jan 26, 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 2 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jan 26, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91284
Drugs@FDA: Overview at FDA
Company: Sagent 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