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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 215693


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NDA 215693 describes EZETIMIBE, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Ohm Labs Inc, Orient Pharma, Rising, Sandoz, Sciegen Pharms Inc, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Ani Pharms, Aurobindo Pharma Usa, and Dr Reddys Labs Sa, and is included in twenty-three NDAs. It is available from twenty-seven 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. Thirteen suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.
Summary for 215693
Tradename:EZETIMIBE
Applicant:Orient Pharma
Ingredient:ezetimibe
Patents:0
Pharmacology for NDA: 215693
Physiological EffectDecreased Cholesterol Absorption
Medical Subject Heading (MeSH) Categories for 215693
Suppliers and Packaging for NDA: 215693
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EZETIMIBE ezetimibe TABLET;ORAL 215693 ANDA Marlex Pharmaceuticals, Inc. 10135-787 10135-787-05 500 TABLET in 1 BOTTLE (10135-787-05)
EZETIMIBE ezetimibe TABLET;ORAL 215693 ANDA Marlex Pharmaceuticals, Inc. 10135-787 10135-787-30 30 TABLET in 1 BOTTLE (10135-787-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 13, 2022TE:ABRLD:No

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