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Generated: April 25, 2018

DrugPatentWatch Database Preview

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. It is available from one supplier. Additional details are available on the GEMZAR profile page.

The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are twenty-nine drug master file entries for this compound. Seventeen 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 020509

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 020509

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509	NDA	Eli Lilly and Company	0002-7501	N	0002-7501-01
GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509	NDA	Eli Lilly and Company	0002-7502	N	0002-7502-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 200MG BASE/VIAL
Approval Date:	May 15, 1996	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	May 15, 1996	TE:	AP	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	020509-002	May 15, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-002	May 15, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Lilly	GEMZAR	gemcitabine hydrochloride	INJECTABLE;INJECTION	020509-001	May 15, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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