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Serving leading biopharmaceutical companies globally:

Merck
Accenture
McKinsey
US Army
AstraZeneca
Fuji
Federal Trade Commission
Colorcon
Express Scripts
Mallinckrodt

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207311

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NDA 207311 describes EZETIMIBE, which is a drug marketed by 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 thirteen NDAs. It is available from thirteen 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. Nine suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

Summary for 207311

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 207311

Suppliers and Packaging for NDA: 207311

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EZETIMIBE ezetimibe TABLET;ORAL 207311 ANDA Ohm Laboratories Inc. 51660-200 51660-200-90 90 TABLET in 1 BOTTLE (51660-200-90)
EZETIMIBE ezetimibe TABLET;ORAL 207311 ANDA Ohm Laboratories Inc. 51660-200 51660-200-30 30 TABLET in 1 BOTTLE (51660-200-30)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 12, 2017TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Dow
Julphar
Queensland Health
QuintilesIMS
Express Scripts
AstraZeneca
Boehringer Ingelheim
Cipla
UBS
Fish and Richardson

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