Details for New Drug Application (NDA): 208476
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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 208476
Tradename: | FENOFIBRATE |
Applicant: | Austarpharma |
Ingredient: | fenofibrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 208476
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 208476 | ANDA | AustarPharma, LLC | 35561-249 | 35561-249-10 | 30 TABLET, FILM COATED in 1 BOTTLE (35561-249-10) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 208476 | ANDA | AustarPharma, LLC | 35561-249 | 35561-249-13 | 500 TABLET, FILM COATED in 1 BOTTLE (35561-249-13) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 48MG | ||||
Approval Date: | Feb 10, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 145MG | ||||
Approval Date: | Feb 10, 2021 | TE: | AB | RLD: | No |
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