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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091284

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NDA 091284 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 091284

Tradename:	TOPOTECAN HYDROCHLORIDE
Applicant:	Sagent Pharms
Ingredient:	topotecan hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 091284

Topoisomerase I Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4MG BASE/VIAL
Approval Date:	Jan 26, 2011	TE:	AP	RLD:	No

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