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Last Updated: April 1, 2026

Details for New Drug Application (NDA): 211159

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NDA 211159 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, Teva Pharms Usa, Watson Labs Inc, Zydus Pharms, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, and Torrent, and is included in twenty-five NDAs. It is available from twenty-four 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. Ten suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

Summary for 211159

Tradename:	EZETIMIBE
Applicant:	Macleods Pharms Ltd
Ingredient:	ezetimibe
Patents:	0

Pharmacology for NDA: 211159

Physiological Effect	Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 211159

Anticholesteremic Agents

Suppliers and Packaging for NDA: 211159

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EZETIMIBE	ezetimibe	TABLET;ORAL	211159	ANDA	Macleods Pharmaceuticals Limited	33342-373	33342-373-07	30 TABLET in 1 BOTTLE (33342-373-07)
EZETIMIBE	ezetimibe	TABLET;ORAL	211159	ANDA	Macleods Pharmaceuticals Limited	33342-373	33342-373-10	90 TABLET in 1 BOTTLE (33342-373-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Apr 29, 2024	TE:		RLD:	No

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