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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202968


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NDA 202968 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, and Watson Labs Inc, and is included in seven NDAs. It is available from twelve 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. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 202968
Tradename:EZETIMIBE AND SIMVASTATIN
Applicant:Watson Labs Inc
Ingredient:ezetimibe; simvastatin
Patents:0
Pharmacology for NDA: 202968
Suppliers and Packaging for NDA: 202968
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 202968 ANDA Actavis Pharma, Inc. 45963-565 45963-565-08 90 TABLET in 1 BOTTLE (45963-565-08)
EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 202968 ANDA Actavis Pharma, Inc. 45963-565 45963-565-30 30 TABLET in 1 BOTTLE (45963-565-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;10MG
Approval Date:Apr 26, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;20MG
Approval Date:Apr 26, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;40MG
Approval Date:Apr 26, 2017TE:ABRLD:No

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