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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208831


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NDA 208831 describes EZETIMIBE AND SIMVASTATIN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Sciegen Pharms Inc, Torrent, and Watson Labs Inc, and is included in nine NDAs. It is available from ten suppliers. Additional details are available on the EZETIMIBE AND SIMVASTATIN profile page.

The generic ingredient in EZETIMIBE AND SIMVASTATIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 208831
Tradename:EZETIMIBE AND SIMVASTATIN
Applicant:Amneal Pharms Co
Ingredient:ezetimibe; simvastatin
Patents:0
Pharmacology for NDA: 208831
Mechanism of ActionHydroxymethylglutaryl-CoA Reductase Inhibitors
Physiological EffectDecreased Cholesterol Absorption
Suppliers and Packaging for NDA: 208831
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831 ANDA AvKARE 42291-078 42291-078-10 1000 TABLET in 1 BOTTLE (42291-078-10)
EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 208831 ANDA AvKARE 42291-079 42291-079-10 1000 TABLET in 1 BOTTLE (42291-079-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;10MG
Approval Date:Nov 21, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;20MG
Approval Date:Nov 21, 2017TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;40MG
Approval Date:Nov 21, 2017TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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