Details for New Drug Application (NDA): 021445

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NDA 021445 describes ZETIA, which is a drug marketed by Organon and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ZETIA profile page.

The generic ingredient in ZETIA is ezetimibe. There are twenty-four drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.

Summary for 021445

Tradename:	ZETIA
Applicant:	Organon
Ingredient:	ezetimibe
Patents:	1

Pharmacology for NDA: 021445

Physiological Effect	Decreased Cholesterol Absorption

Medical Subject Heading (MeSH) Categories for 021445

Anticholesteremic Agents

Suppliers and Packaging for NDA: 021445

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZETIA	ezetimibe	TABLET;ORAL	021445	NDA	Organon LLC	78206-178	78206-178-01	30 TABLET in 1 BOTTLE (78206-178-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 25, 2002	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Apr 30, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021445

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
Organon	ZETIA	ezetimibe	TABLET;ORAL	021445-001	Oct 25, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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