Details for New Drug Application (NDA): 206084

NDA 206084 describes LYPQOZET, which is a drug marketed by Althera Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the LYPQOZET profile page.

The generic ingredient in LYPQOZET is atorvastatin calcium; ezetimibe. There are sixty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the atorvastatin calcium; ezetimibe profile page.

Summary for 206084

Tradename:	LYPQOZET
Applicant:	Althera Pharms
Ingredient:	atorvastatin calcium; ezetimibe
Patents:	0

Pharmacology for NDA: 206084

Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors
Physiological Effect	Decreased Cholesterol Absorption

Suppliers and Packaging for NDA: 206084

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084	ANDA	Althera Pharmaceuticals, LLC	70661-005	70661-005-30	30 TABLET in 1 BOTTLE (70661-005-30)
LYPQOZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	206084	ANDA	Althera Pharmaceuticals, LLC	70661-005	70661-005-90	90 TABLET in 1 BOTTLE (70661-005-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;10MG
Approval Date:	Apr 26, 2017	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE;10MG
Approval Date:	Apr 26, 2017	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE;10MG
Approval Date:	Apr 26, 2017	TE:		RLD:	No

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