Application 206617

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MG BASE/VIAL	No	No
002	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9394	Gemcitabine	Gemcitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9395	Gemcitabine	Gemcitabine	Hikma Pharmaceuticals USA Inc.	ANDA	Current