Details for New Drug Application (NDA): 217732
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The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 217732
Tradename: | FENOFIBRATE |
Applicant: | Creekwood Pharms |
Ingredient: | fenofibrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 217732
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 217732 | ANDA | Creekwood Pharmaceuticals LLC | 82619-101 | 82619-101-01 | 90 TABLET in 1 BOTTLE (82619-101-01) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 217732 | ANDA | Creekwood Pharmaceuticals LLC | 82619-102 | 82619-102-01 | 90 TABLET in 1 BOTTLE (82619-102-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
Approval Date: | Sep 7, 2023 | TE: | BX | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
Approval Date: | Sep 7, 2023 | TE: | BX | RLD: | No |
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