Details for New Drug Application (NDA): 020509

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NDA 020509 describes GEMZAR, which is a drug marketed by Lilly and is included in one NDA. Additional details are available on the GEMZAR profile page.

The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for 020509

Tradename:	GEMZAR
Applicant:	Lilly
Ingredient:	gemcitabine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 15, 1996	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 15, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020509

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996	⤷ Sign Up	⤷ Sign Up
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-002	May 15, 1996	⤷ Sign Up	⤷ Sign Up
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996	⤷ Sign Up	⤷ Sign Up
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-002	May 15, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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