Details for New Drug Application (NDA): 216798
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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 216798
Tradename: | FENOFIBRATE |
Applicant: | Aurobindo Pharma |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 216798
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 216798 | ANDA | Aurobindo Pharma Limited | 59651-575 | 59651-575-90 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-575-90) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 216798 | ANDA | Aurobindo Pharma Limited | 59651-576 | 59651-576-90 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-576-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 54MG | ||||
Approval Date: | Sep 27, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Sep 27, 2022 | TE: | AB | RLD: | No |
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