Details for New Drug Application (NDA): 208803

NDA 208803 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 208803

Tradename:	EZETIMIBE
Applicant:	Amneal Pharms Co
Ingredient:	ezetimibe
Patents:	0

Pharmacology for NDA: 208803

Physiological Effect

Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 208803

Anticholesteremic Agents

Suppliers and Packaging for NDA: 208803

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EZETIMIBE	ezetimibe	TABLET;ORAL	208803	ANDA	AvPAK	50268-298	50268-298-12	20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-298-12) / 1 TABLET in 1 BLISTER PACK (50268-298-11)
EZETIMIBE	ezetimibe	TABLET;ORAL	208803	ANDA	Amneal Pharmaceuticals NY LLC	69238-1154	69238-1154-1	1000 TABLET in 1 BOTTLE (69238-1154-1)

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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