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Profile for Tradename: GEMZAR

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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. Two 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

Suppliers / Packagers: see list2

Pharmacology for Tradename: GEMZAR

Clinical Trials for: GEMZAR

Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
Status: Recruiting Condition: Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Digestive System Diseases; Endocrine System Diseases; Gemcitabine; Antimetabolites, Antineoplastic

Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
Status: Completed Condition: Ovarian Cancer; Primary Peritoneal Cancer

Intrathecal Gemcitabine to Treat Neoplastic Meningitis, IT Gemcitabine
Status: Terminated Condition: Meningitis; Neoplasms

Gemcitabine/Clofarabine/Busulfan and Allogeneic Transplantation for Aggressive Lymphomas
Status: Recruiting Condition: Lymphoma

PP-Gemcitabine & External Beam Radiation-Sarcomas
Status: Completed Condition: Sarcoma

A Two-Dimensional Dose-Finding Study of Ixazomib in Combination With Gemcitabine and Doxorubicin, Followed by a Phase II Extension to Assess the Efficacy of This Combination in Metastatic, Surgically Unresectable Urothelial Cancer
Status: Recruiting Condition: Bladder Cancer

Gemcitabine, Cisplatin, and Abraxane in Advanced Biliary Cancers
Status: Recruiting Condition: Biliary Tract Cancer

Gemcitabine and ON 01910.Na in Previously Untreated Metastatic Pancreatic Cancer
Status: Active, not recruiting Condition: Metastatic Pancreatic Adenocarcinoma

Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
Status: Active, not recruiting Condition: Solid Tumor; Urethral Cancer

Trial of Gemcitabine With or Without Bavituximab in Patients With Previously Untreated Stage IV Pancreatic Cancer
Status: Completed Condition: Metastatic Pancreatic Cancer

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 1996RXYes<disabled><disabled>
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 1996RXYes<disabled><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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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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