Details for New Drug Application (NDA): 200199

NDA 200199 describes TOPOTECAN, which is a drug marketed by Sandoz Inc, 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 sixteen NDAs. Additional details are available on the TOPOTECAN profile page.

The generic ingredient in TOPOTECAN 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 200199

Tradename:	TOPOTECAN
Applicant:	Sandoz Inc
Ingredient:	topotecan hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 200199

Topoisomerase I Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 25, 2011	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 25, 2011	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Feb 25, 2011	TE:		RLD:	Yes

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