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Generated: September 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021445

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NDA 021445 describes ZETIA, which is a drug marketed by Msd Intl Gmbh and is included in one NDA. It is available from four suppliers. There are two patents 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-one suppliers are listed for this compound. Additional details are available on the ezetimibe profile page.
Summary for 021445
Tradename:ZETIA
Applicant:Msd Intl Gmbh
Ingredient:ezetimibe
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021445
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 Rebel Distributors Corp 21695-778 21695-778-30 30 TABLET in 1 BOTTLE (21695-778-30)
ZETIA ezetimibe TABLET;ORAL 021445 NDA Rebel Distributors Corp 21695-778 21695-778-90 90 TABLET in 1 BOTTLE (21695-778-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 25, 2002TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 25, 2022Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free 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
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Msd Intl Gmbh ZETIA ezetimibe TABLET;ORAL 021445-001 Oct 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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