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Last Updated: August 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019304

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NDA 019304 describes TRICOR (MICRONIZED), which is a drug marketed by Abbvie and is included in one NDA. Additional details are available on the TRICOR (MICRONIZED) profile page.

The generic ingredient in TRICOR (MICRONIZED) 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 019304
Tradename:TRICOR (MICRONIZED)
Applicant:Abbvie
Ingredient:fenofibrate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 019304
Paragraph IV (Patent) Challenges for 019304
Tradename Dosage Ingredient NDA Submissiondate
TRICOR (MICRONIZED) CAPSULE;ORAL fenofibrate 019304
LIPIDIL CAPSULE;ORAL fenofibrate 019304

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 31, 1993TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength67MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Feb 9, 1998TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength134MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 30, 1999TE:RLD:Yes

Expired US Patents for NDA 019304

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie LIPIDIL fenofibrate CAPSULE;ORAL 019304-001 Dec 31, 1993   Start Trial   Start Trial
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-003 Jun 30, 1999   Start Trial   Start Trial
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-002 Feb 9, 1998   Start Trial   Start Trial
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-004 Jun 30, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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