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Gemcitabine hydrochloride - Generic Drug Details

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Gemcitabine hydrochloride is the generic ingredient in two branded drugs marketed by Lilly, Gland Pharma Ltd, Luitpold Pharms Inc, Sun Pharma Global, Hospira, Fresenius Kabi Usa, Mylan Labs Ltd, Actavis Inc, Cipla Ltd, Actavis Totowa, Emcure Pharms Ltd, Hameln Rds Gmbh, Dr Reddys Labs Ltd, Hospira Inc, Teva Pharms, Jiangsu Hansoh Pharm, Accord Hlthcare, Sagent Pharms, and Fresenius Kabi Oncol, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for gemcitabine hydrochloride. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: gemcitabine hydrochloride

Tradenames:2
Patents:0
Applicants:19
NDAs:21
Drug Master File Entries: see list27
Suppliers / Packaging: see list16
Formulation / Manufacturing:see details

Pharmacology for Ingredient: gemcitabine hydrochloride

Tentative approvals for GEMCITABINE HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTIONEQ 200MG BASE/VIAL
<disabled><disabled>INJECTABLE; INJECTIONEQ 1GM BASE/VIAL

Clinical Trials for: gemcitabine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland Pharma Ltd
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION204520-001Jan 5, 2016RXNo<disabled><disabled>
Fresenius Kabi Oncol
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION090799-003May 16, 2011RXNo<disabled><disabled>
Mylan Labs Ltd
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION200145-002Jul 25, 2011RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: gemcitabine hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19964,808,614*PED<disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19964,808,614*PED<disabled>
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-001May 15, 19965,464,826*PED<disabled>
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