Last Updated: September 24, 2026

Details for New Drug Application (NDA): 022453

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NDA 022453 describes TOPOTECAN HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Ingenus Pharms Llc, Meitheal, Rising, Sagent Pharms, Sun Pharm Inds Ltd, Teyro Labs, Hospira Inc, and Natco Pharma Usa, 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 is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the topotecan hydrochloride profile page.

Summary for 022453

Tradename:	TOPOTECAN HYDROCHLORIDE
Applicant:	Meitheal
Ingredient:	topotecan hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 022453

Topoisomerase I Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:	Dec 20, 2012	TE:		RLD:	No

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