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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 200153

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NDA 200153 describes LIPTRUZET, which is a drug marketed by Organon and is included in one NDA. Additional details are available on the LIPTRUZET profile page.

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

Summary for 200153

Tradename:	LIPTRUZET
Applicant:	Organon
Ingredient:	atorvastatin calcium; ezetimibe
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 3, 2013	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 3, 2013	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 40MG BASE;10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 3, 2013	TE:		RLD:	Yes

Expired US Patents for NDA 200153

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013	⤷ Get Started Free	⤷ Get Started Free
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-004	May 3, 2013	⤷ Get Started Free	⤷ Get Started Free
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-003	May 3, 2013	⤷ Get Started Free	⤷ Get Started Free
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-001	May 3, 2013	⤷ Get Started Free	⤷ Get Started Free
Organon	LIPTRUZET	atorvastatin calcium; ezetimibe	TABLET;ORAL	200153-002	May 3, 2013	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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