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Last Updated: April 25, 2024

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
Formulation / Manufacturing:see details

Profile for product number 001

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200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 15, 1996TE:RLD: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 020509-001 May 15, 1996 ⤷  Try a Trial ⤷  Try a Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996 ⤷  Try a Trial ⤷  Try a Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ⤷  Try a Trial ⤷  Try a Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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