Application 091594

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
003	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-092	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-092	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-092	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-117	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-117	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-117	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-118	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-118	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
16729-118	GEMCITABINE HYDROCHLORIDE	GEMCITABINE HYDROCHLORIDE	Accord Healthcare Inc.	ANDA	Current
68001-282	Gemcitabine Hydrochloride	Gemcitabine Hydrochloride	BluePoint Laboratories	ANDA	Current
68001-282	Gemcitabine Hydrochloride	Gemcitabine Hydrochloride	BluePoint Laboratories	ANDA	Current