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Generated: December 18, 2017

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-two NDAs. It is available from sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.

Summary for 079183

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 0409-0187-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0187-01) > 50 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:Nov 15, 2010TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Julphar
Johnson and Johnson
Harvard Business School
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US Army
Boehringer Ingelheim
QuintilesIMS
Cipla
McKinsey
Fuji

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