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Last Updated: March 28, 2024

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-seven 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021445
Physiological EffectDecreased Cholesterol Absorption
Medical Subject Heading (MeSH) Categories for 021445
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:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 25, 2002TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Apr 30, 2026Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021445

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

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