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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 091376

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NDA 091376 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Meitheal, Novast Labs, Rising, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Dash Pharms, and Hospira Inc, and is included in fifteen NDAs. It is available from five suppliers. Additional details are available on the TOPOTECAN HYDROCHLORIDE profile page.

The generic ingredient in TOPOTECAN HYDROCHLORIDE is topotecan hydrochloride. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for 091376

Tradename:	TOPOTECAN HYDROCHLORIDE
Applicant:	Fresenius Kabi Usa
Ingredient:	topotecan hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 091376

Topoisomerase I Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4MG BASE/VIAL
Approval Date:	Nov 29, 2010	TE:		RLD:	No

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