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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 200909


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NDA 200909 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 200909
Tradename:EZETIMIBE AND SIMVASTATIN
Applicant:Dr Reddys Labs Sa
Ingredient:ezetimibe; simvastatin
Patents:0
Pharmacology for NDA: 200909
Suppliers and Packaging for NDA: 200909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909 ANDA Dr.Reddys Laboratories Inc 43598-742 43598-742-10 1000 TABLET in 1 BOTTLE (43598-742-10)
EZETIMIBE AND SIMVASTATIN ezetimibe; simvastatin TABLET;ORAL 200909 ANDA Dr.Reddys Laboratories Inc 43598-742 43598-742-30 30 TABLET in 1 BOTTLE (43598-742-30)

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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