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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Queensland Health
Johnson and Johnson
Deloitte
Chubb
Covington
Baxter
AstraZeneca
McKinsey

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
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:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:May 15, 1996TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:May 15, 1996TE:APRLD:Yes

Expired US Patents for NDA 020509

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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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cantor Fitzgerald
Johnson and Johnson
Baxter
Express Scripts
US Army
Argus Health
Accenture
Healthtrust

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