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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090620

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NDA 090620 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 090620

Tradename:	TOPOTECAN HYDROCHLORIDE
Applicant:	Actavis Totowa
Ingredient:	topotecan hydrochloride
Patents:	0

Pharmacology for NDA: 090620

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 090620

Topoisomerase I Inhibitors

Suppliers and Packaging for NDA: 090620

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	INJECTABLE;INJECTION	090620	ANDA	Actavis Pharma, Inc.	45963-615	45963-615-56	1 VIAL in 1 CARTON (45963-615-56) / 4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 4MG BASE/VIAL
Approval Date:	Dec 2, 2010	TE:	AP	RLD:	No

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