Application 200199

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPOTECAN	TOPOTECAN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 1MG BASE/ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	TOPOTECAN	TOPOTECAN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 3MG BASE/3ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	TOPOTECAN	TOPOTECAN HYDROCHLORIDE	SOLUTION;INTRAVENOUS	EQ 4MG BASE/4ML (EQ 1MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66758-051	Topotecan	Topotecan	Sandoz Inc	NDA	Current