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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 078724

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NDA 078724 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 078724

Tradename:	EZETIMIBE
Applicant:	Teva Pharms Usa
Ingredient:	ezetimibe
Patents:	0

Medical Subject Heading (MeSH) Categories for 078724

Anticholesteremic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 12, 2017	TE:		RLD:	No

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