Details for New Drug Application (NDA): 209234

NDA 209234 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 209234

Tradename:	EZETIMIBE
Applicant:	Alkem Labs Ltd
Ingredient:	ezetimibe
Patents:	0

Pharmacology for NDA: 209234

Physiological Effect

Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 209234

Anticholesteremic Agents

Suppliers and Packaging for NDA: 209234

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EZETIMIBE	ezetimibe	TABLET;ORAL	209234	ANDA	Major Pharmaceuticals	0904-7103	0904-7103-04	30 BLISTER PACK in 1 CARTON (0904-7103-04) / 1 TABLET in 1 BLISTER PACK
EZETIMIBE	ezetimibe	TABLET;ORAL	209234	ANDA	Major Pharmaceuticals	0904-7103	0904-7103-10	20 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 21, 2017	TE:	AB	RLD:	No

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