Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Medtronic
Cantor Fitzgerald
Harvard Business School
Colorcon
Fish and Richardson
Covington
Teva
Chubb

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200795

« Back to Dashboard

NDA 200795 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 200795
Tradename:GEMCITABINE HYDROCHLORIDE
Applicant:Hospira Inc
Ingredient:gemcitabine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200795
Suppliers and Packaging for NDA: 200795
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200795 NDA Hospira, Inc. 0409-0181 N 0409-0181-01
GEMCITABINE HYDROCHLORIDE gemcitabine hydrochloride INJECTABLE;INJECTION 200795 NDA Hospira, Inc. 0409-0181 N 0409-0181-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/5.26ML (38MG/ML)
Approval Date:Aug 4, 2011TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1GM/26.3ML (38MG/ML)
Approval Date:Aug 4, 2011TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2GM/52.6ML (38MG/ML)
Approval Date:Aug 4, 2011TE:APRLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Teva
Chinese Patent Office
Chubb
Julphar
Mallinckrodt
AstraZeneca
Federal Trade Commission
Harvard Business School
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.