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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Deloitte
QuintilesIMS
Chubb
Johnson and Johnson
Queensland Health
Julphar
Fuji
McKesson

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090242

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NDA 090242 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 090242

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 090242

Suppliers and Packaging for NDA: 090242

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090242 ANDA Fresenius Kabi USA, LLC 63323-126 63323-126-00 1 VIAL in 1 CARTON (63323-126-00) > 50 mL in 1 VIAL
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 090242 ANDA Fresenius Kabi USA, LLC 63323-126 63323-126-03 1 VIAL, SINGLE-USE in 1 BOX (63323-126-03) > 50 mL in 1 VIAL, SINGLE-USE

Summary 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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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Fish and Richardson
Express Scripts
Teva
Medtronic
Federal Trade Commission
Novartis
Accenture
Deloitte
QuintilesIMS

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