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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090799

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NDA 090799 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 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 090799
Tradename:GEMCITABINE HYDROCHLORIDE
Applicant:Fresenius Kabi Oncol
Ingredient:gemcitabine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090799
Suppliers and Packaging for NDA: 090799
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090799 ANDA Fresenius Kabi USA, LLC 63323-102 E 63323-102-13
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090799 ANDA Fresenius Kabi USA, LLC 63323-102 E 63323-102-94

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

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL
Approval Date:May 16, 2011TE:APRLD:No

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