Details for New Drug Application (NDA): 022418
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The generic ingredient in FIBRICOR is fenofibric acid. There are four drug master file entries 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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 35MG | ||||
Approval Date: | Aug 14, 2009 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID LEVELS |
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