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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Teva
Express Scripts
Fish and Richardson
US Army
Mallinckrodt
Federal Trade Commission
Johnson and Johnson

Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078885

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NDA 078885 describes LEUPROLIDE ACETATE, which is a drug marketed by Genzyme, Sandoz, Sun Pharma Global, and Teva Pharms Usa, and is included in four NDAs. It is available from three suppliers. Additional details are available on the LEUPROLIDE ACETATE profile page.

The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
Summary for 078885
Tradename:LEUPROLIDE ACETATE
Applicant:Sun Pharma Global
Ingredient:leuprolide acetate
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078885
Suppliers and Packaging for NDA: 078885
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUPROLIDE ACETATE leuprolide acetate INJECTABLE;INJECTION 078885 ANDA Sun Pharma Global FZE 47335-936 N 47335-936-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/0.2ML
Approval Date:Mar 9, 2009TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
McKesson
Mallinckrodt
QuintilesIMS
Harvard Business School
US Department of Justice
McKinsey
Chinese Patent Office
Julphar

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