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Serving 500+ biopharmaceutical companies globally:

Medtronic
Accenture
Fish and Richardson
Boehringer Ingelheim
Merck
Colorcon
Julphar
Queensland Health
QuintilesIMS
Johnson and Johnson

Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078560

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NDA 078560 describes EZETIMIBE, which is a drug marketed by Amneal Pharms Co, Ohm Labs Inc, Teva Pharms Usa, Sandoz Inc, Watson Labs Inc, Zydus Pharms Usa Inc, Apotex Inc, Glenmark Pharms Ltd, Watson Labs Teva, Dr Reddys Labs Sa, and Impax Labs Inc, and is included in twelve NDAs. It is available from eleven 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 NDA: 078560

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

Pharmacology for NDA: 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 Par Pharmaceutical Inc 49884-228 49884-228-05 500 TABLET in 1 BOTTLE (49884-228-05)
EZETIMIBE
ezetimibe
TABLET;ORAL 078560 ANDA Par Pharmaceutical Inc 49884-228 49884-228-09 90 TABLET in 1 BOTTLE (49884-228-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 26, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Jun 10, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE


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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Chinese Patent Office
Merck
Cipla
Fuji
Chubb
Cerilliant
Healthtrust
Federal Trade Commission
US Army

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.

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