Details for New Drug Application (NDA): 207803
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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 207803
Tradename: | FENOFIBRATE |
Applicant: | Austarpharma |
Ingredient: | fenofibrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 207803
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 207803 | ANDA | AvKARE | 42291-427 | 42291-427-50 | 500 TABLET, FILM COATED in 1 BOTTLE (42291-427-50) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 207803 | ANDA | AvKARE | 42291-427 | 42291-427-90 | 90 TABLET, FILM COATED in 1 BOTTLE (42291-427-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 54MG | ||||
Approval Date: | Dec 19, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Dec 19, 2017 | TE: | AB | RLD: | No |
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