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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-seven drug master file entries for this compound. Seventeen suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for NDA: 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 0002-7501-01 5 mL in 1 VIAL (0002-7501-01)
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION 020509 NDA Eli Lilly and Company 0002-7502 0002-7502-01 25 mL in 1 VIAL (0002-7502-01)

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book 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;INJECTION020509-002May 15, 19964,808,614*PED► subscribe
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19965,464,826*PED► subscribe
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19964,808,614*PED► subscribe
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