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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. Seventeen 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 list17
Formulation / Manufacturing:see details
Drug Prices:see low prices

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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hameln Rds Gmbh
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION090663-001Sep 10, 2012RXNo► subscribe► subscribe
Accord Hlthcare
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION091594-003Jul 25, 2011RXNo► subscribe► subscribe
Fresenius Kabi Usa
GEMCITABINE HYDROCHLORIDE
gemcitabine hydrochloride
INJECTABLE;INJECTION090242-003May 16, 2011RXNo► subscribe► subscribe
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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► subscribe
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19965,464,826*PED► subscribe
Lilly
GEMZAR
gemcitabine hydrochloride
INJECTABLE;INJECTION020509-002May 15, 19964,808,614*PED► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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