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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 Aralez Pharms Inc and is included in one NDA. It is available from five suppliers. 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 five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the fenofibric acid profile page.

Summary for NDA: 022418

Tradename:
FIBRICOR
Applicant:
Aralez Pharms Inc
Ingredient:
fenofibric acid
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 022418

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 AR Scientific, Inc. 13310-101 13310-101-01 100 TABLET in 1 BOTTLE, PLASTIC (13310-101-01)
FIBRICOR
fenofibric acid
TABLET;ORAL 022418 NDA AR Scientific, Inc. 13310-101 13310-101-03 250 TABLET in 1 BOTTLE, PLASTIC (13310-101-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:Aug 14, 2009TE:RLD:No
Patent:7,741,374Patent Expiration:Aug 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS
Patent:7,569,612Patent Expiration:Aug 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
Patent:7,915,247Patent Expiration:Aug 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS


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