MEITHEAL Application 201166

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 4MG BASE/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71288-127	Topotecan	Topotecan Hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current
71288-127	Topotecan	Topotecan Hydrochloride	Meitheal Pharmaceuticals Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
22846	ORIG	2013-02-26