Details for New Drug Application (NDA): 211080
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The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 211080
Tradename: | FENOFIBRATE |
Applicant: | Prinston Inc |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 211080
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 211080 | ANDA | Solco Healthcare US, LLC | 43547-430 | 43547-430-09 | 90 TABLET in 1 BOTTLE (43547-430-09) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 211080 | ANDA | Solco Healthcare US, LLC | 43547-430 | 43547-430-50 | 500 TABLET in 1 BOTTLE (43547-430-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 48MG | ||||
Approval Date: | Aug 28, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 145MG | ||||
Approval Date: | Aug 28, 2018 | TE: | AB | RLD: | No |
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