Details for New Drug Application (NDA): 200831

NDA 200831 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 200831

Tradename:	EZETIMIBE
Applicant:	Watson Labs Inc
Ingredient:	ezetimibe
Patents:	0

Pharmacology for NDA: 200831

Physiological Effect

Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 200831

Anticholesteremic Agents

Suppliers and Packaging for NDA: 200831

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EZETIMIBE	ezetimibe	TABLET;ORAL	200831	ANDA	Actavis Pharma, Inc.	0591-3713	0591-3713-05	500 TABLET in 1 BOTTLE (0591-3713-05)
EZETIMIBE	ezetimibe	TABLET;ORAL	200831	ANDA	Actavis Pharma, Inc.	0591-3713	0591-3713-19	90 TABLET in 1 BOTTLE (0591-3713-19)

Profile for product number 001

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

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