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Last Updated: May 30, 2020

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Details for New Drug Application (NDA): 021203


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NDA 021203 describes TRICOR, which is a drug marketed by Abbvie and Abbvie Inc and is included in three NDAs. It is available from six suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRICOR profile page.

The generic ingredient in TRICOR is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 021203
Tradename:TRICOR
Applicant:Abbvie Inc
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021203
Paragraph IV (Patent) Challenges for 021203
Tradename Dosage Ingredient NDA Submissiondate
TRICOR TABLET;ORAL fenofibrate 021203

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength54MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 4, 2001TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength160MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Sep 4, 2001TE:RLD:Yes

Expired US Patents for NDA 021203

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001   Start Trial   Start Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001   Start Trial   Start Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001   Start Trial   Start Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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