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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078560

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NDA 078560 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, Dr Reddys Labs Sa, and Torrent, and is included in twenty-five NDAs. It is available from twenty-six 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 078560

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

Pharmacology for NDA: 078560

Physiological Effect	Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 078560

Anticholesteremic Agents

Suppliers and Packaging for NDA: 078560

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EZETIMIBE	ezetimibe	TABLET;ORAL	078560	ANDA	A-S Medication Solutions	50090-7338	50090-7338-0	90 TABLET in 1 BOTTLE (50090-7338-0)
EZETIMIBE	ezetimibe	TABLET;ORAL	078560	ANDA	A-S Medication Solutions	50090-7339	50090-7339-0	30 TABLET in 1 BOTTLE (50090-7339-0)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 26, 2015	TE:	AB	RLD:	No

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