Details for New Drug Application (NDA): 021687

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NDA 021687 describes VYTORIN, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. Additional details are available on the VYTORIN profile page.

The generic ingredient in VYTORIN 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 021687

Tradename:	VYTORIN
Applicant:	Organon
Ingredient:	ezetimibe; simvastatin
Patents:	0

Pharmacology for NDA: 021687

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

Suppliers and Packaging for NDA: 021687

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687	NDA	Organon LLC	78206-174	78206-174-01	30 TABLET in 1 BOTTLE (78206-174-01)
VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687	NDA	Organon LLC	78206-174	78206-174-02	90 TABLET in 1 BOTTLE (78206-174-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;10MG
Approval Date:	Jul 23, 2004	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;20MG
Approval Date:	Jul 23, 2004	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG;40MG
Approval Date:	Jul 23, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021687

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004	⤷ Sign Up	⤷ Sign Up
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	⤷ Sign Up	⤷ Sign Up
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-003	Jul 23, 2004	⤷ Sign Up	⤷ Sign Up
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004	⤷ Sign Up	⤷ Sign Up
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-004	Jul 23, 2004	⤷ Sign Up	⤷ Sign Up
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687-001	Jul 23, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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