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Last Updated: September 24, 2022

Details for New Drug Application (NDA): 021656


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NDA 021656 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 two 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-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 021656
Tradename:TRICOR
Applicant:Abbvie
Ingredient:fenofibrate
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021656
Medical Subject Heading (MeSH) Categories for 021656
Suppliers and Packaging for NDA: 021656
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRICOR fenofibrate TABLET;ORAL 021656 NDA AbbVie Inc. 0074-3173 0074-3173-90 90 TABLET in 1 BOTTLE (0074-3173-90)
TRICOR fenofibrate TABLET;ORAL 021656 NDA AbbVie Inc. 0074-3189 0074-3189-90 90 TABLET in 1 BOTTLE (0074-3189-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength48MG
Approval Date:Nov 5, 2004TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 21, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Feb 21, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength145MG
Approval Date:Nov 5, 2004TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Feb 21, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021656

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004 See Plans and Pricing See Plans and Pricing
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004 See Plans and Pricing See Plans and Pricing
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-001 Nov 5, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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