Gemcitabine - Generic Drug Details

See drug prices for gemcitabine

Generic filers with tentative approvals for GEMCITABINE

Applicant	Application No.	Strength	Dosage Form
		200MG	INJECTABLE; INJECTION
		2G	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for gemcitabine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	077983-001	Jan 25, 2011		DISCN	No	No
Norvium Bioscience	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	200145-001	Jul 25, 2011		DISCN	No	No
Accord Hlthcare	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	209604-002	Aug 3, 2017		RX	Yes	Yes
Hikma	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	213175-002	Mar 7, 2023	AP	RX	No	No
Sun Pharm	INFUGEM	gemcitabine hydrochloride	SOLUTION;INTRAVENOUS	208313-004	Jul 16, 2018		DISCN	Yes	No			Y
Novast Labs	GEMCITABINE HYDROCHLORIDE	gemcitabine hydrochloride	INJECTABLE;INJECTION	210383-002	Feb 14, 2019	AP	RX	No	No