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. 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. Additional details are available on the fenofibric acid profile page.
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 |
| Formulation / Manufacturing: | see details |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 35MG | ||||
| Approval Date: | Aug 14, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA | ||||||||
| Patent: | ⤷ Try a Trial | 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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