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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204406

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NDA 204406 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 204406

Tradename:	TOPOTECAN HYDROCHLORIDE
Applicant:	Accord Hlthcare
Ingredient:	topotecan hydrochloride
Patents:	0

Pharmacology for NDA: 204406

Mechanism of Action	Topoisomerase Inhibitors

Medical Subject Heading (MeSH) Categories for 204406

Topoisomerase I Inhibitors

Suppliers and Packaging for NDA: 204406

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOPOTECAN HYDROCHLORIDE	topotecan hydrochloride	SOLUTION;INTRAVENOUS	204406	ANDA	Accord Healthcare Inc.	16729-243	16729-243-31	1 VIAL, MULTI-DOSE in 1 CARTON (16729-243-31) / 4 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Approval Date:	Jul 6, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Approval Date:	Jul 6, 2017	TE:	AP	RLD:	No

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