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Generated: December 15, 2018

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Details for New Drug Application (NDA): 078339

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NDA 078339 describes GEMCITABINE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Actavis Inc, Actavis Totowa, Apotex Inc, Cipla, 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, Mylan Labs Ltd, Sagent Pharms, Sun Pharma Global, and Teva Pharms, and is included in twenty-four NDAs. It is available from fifteen 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 078339
Tradename:GEMCITABINE HYDROCHLORIDE
Applicant:Hospira
Ingredient:gemcitabine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078339
Suppliers and Packaging for NDA: 078339
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078339 ANDA Hospira, Inc. 0409-0185 0409-0185-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0185-01) > 5 mL in 1 VIAL, SINGLE-DOSE
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 078339 ANDA Hospira, Inc. 0409-0186 0409-0186-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0186-01) > 25 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Jul 25, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:Jul 25, 2011TE:APRLD:No

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