You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 12, 2025

Details for New Drug Application (NDA): 215693

✉ Email this page to a colleague

« Back to Dashboard

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, 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 215693

Tradename:	EZETIMIBE
Applicant:	Orient Pharma
Ingredient:	ezetimibe
Patents:	0

Pharmacology for NDA: 215693

Physiological Effect	Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 215693

Anticholesteremic Agents

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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 13, 2022	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.