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Last Updated: April 10, 2021

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Details for New Drug Application (NDA): 022418

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NDA 022418 describes FIBRICOR, which is a drug marketed by Athena and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the FIBRICOR profile page.

The generic ingredient in FIBRICOR is fenofibric acid. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fenofibric acid profile page.
Summary for 022418
Tradename:FIBRICOR
Applicant:Athena
Ingredient:fenofibric acid
Patents:4
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022418
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FIBRICOR fenofibric acid TABLET;ORAL 022418 NDA AUTHORIZED GENERIC Palmetto Pharmaceuticals, Inc 68134-601 68134-601-30 30 TABLET in 1 BOTTLE, PLASTIC (68134-601-30)
FIBRICOR fenofibric acid TABLET;ORAL 022418 NDA AUTHORIZED GENERIC Palmetto Pharmaceuticals, Inc 68134-602 68134-602-30 30 TABLET in 1 BOTTLE, PLASTIC (68134-602-30)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength35MG
Approval Date:Aug 14, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
Patent:  Start TrialPatent Expiration:Aug 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA
Patent:  Start TrialPatent Expiration:Aug 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS

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