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Last Updated: November 28, 2021

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, Am Regent, Apotex, Cipla, Dr Reddys Labs Ltd, Emcure Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hameln Rds Gmbh, Hikma Intl Pharms, Hospira, Hospira Inc, Jiangsu Hansoh Pharm, Meitheal, Mylan Labs Ltd, Novast Labs, Sagent Pharms, Sagent Pharms Inc, Shilpa, Sun Pharm, and Teva Pharms, and is included in twenty-nine NDAs. It is available from thirteen suppliers. Additional details are available on the GEMCITABINE HYDROCHLORIDE profile page.

The generic ingredient in GEMCITABINE HYDROCHLORIDE is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Fourteen 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 0409-0187-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0187-01) > 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

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

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