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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Federal Trade Commission

Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079183

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NDA 079183 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Apotex Inc, Cipla Ltd, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Luitpold Pharms Inc, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Teva Pharms, and is included in twenty-three NDAs. It is available from seventeen suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are twenty-nine drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 079183
Applicant:Hospira Inc
Ingredient:gemcitabine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 079183
Suppliers and Packaging for NDA: 079183
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 079183 ANDA Hospira, Inc. 0409-0187 N 0409-0187-01

Profile for product number 001

Approval Date:Nov 15, 2010TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
Harvard Business School
Chinese Patent Office

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