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GEMZAR Drug Profile

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Gemzar is a drug marketed by Lilly and is included in one NDA. It is available from one supplier.

The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for Tradename: GEMZAR

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: GEMZAR

Clinical Trials for: GEMZAR

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 1996RXYes<disabled><disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 1996RXYes<disabled><disabled>
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Expired Patents for Tradename: GEMZAR

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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<disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19964,808,614*PED<disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19965,464,826*PED<disabled>
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Paragraph IV activity for: GEMZAR

Drugname Dosage Strength RLD Submissiondate
gemcitabineFor Injection2 g/vialGemzar8/24/2007
gemcitabineFor Injection1g/vialGemzar11/14/2005
gemcitabineFor Injection200 mg/vialGemzar11/1/2005
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