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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Mallinckrodt
QuintilesIMS
US Army
Cipla
Citi
Healthtrust
Express Scripts
Fish and Richardson

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078560

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NDA 078560 describes EZETIMIBE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Ohm Labs Inc, Sandoz Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms Usa Inc, Watson Labs Teva, Dr Reddys Labs Sa, and Impax Labs Inc, and is included in sixteen NDAs. It is available from fifteen suppliers. Additional details are available on the EZETIMIBE profile page.

The generic ingredient in EZETIMIBE is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 078560
Tradename:EZETIMIBE
Applicant:Glenmark Pharms Ltd
Ingredient:ezetimibe
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078560
Medical Subject Heading (MeSH) Categories for 078560
Suppliers and Packaging for NDA: 078560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EZETIMIBE ezetimibe TABLET;ORAL 078560 ANDA American Health Packaging 60687-284 N 60687-284-21
EZETIMIBE ezetimibe TABLET;ORAL 078560 ANDA Glenmark Pharmaceuticals Inc., USA 68462-226 N 68462-226-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 26, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Deloitte
Daiichi Sankyo
US Department of Justice
Medtronic
Cipla
Chinese Patent Office
Queensland Health
Fuji

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