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Generated: November 18, 2018

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Details for New Drug Application (NDA): 207311

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NDA 207311 describes EZETIMIBE, which is a drug marketed by Alkem Labs Ltd, 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, Ani Pharms Inc, and Dr Reddys Labs Sa, and is included in sixteen NDAs. It is available from nineteen 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. Eleven suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 207311
Tradename:EZETIMIBE
Applicant:Ohm Labs Inc
Ingredient:ezetimibe
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207311
Medical Subject Heading (MeSH) Categories for 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 51660-200-05 500 TABLET in 1 BOTTLE (51660-200-05)
EZETIMIBE ezetimibe TABLET;ORAL 207311 ANDA Ohm Laboratories Inc. 51660-200 51660-200-30 30 TABLET in 1 BOTTLE (51660-200-30)

Profile for product number 001

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

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