Details for New Drug Application (NDA): 090715
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The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.
Summary for 090715
Tradename: | FENOFIBRATE |
Applicant: | Valeant Pharms North |
Ingredient: | fenofibrate |
Patents: | 0 |
Suppliers and Packaging for NDA: 090715
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 090715 | ANDA | Proficient Rx LP | 71205-050 | 71205-050-90 | 90 TABLET in 1 BOTTLE (71205-050-90) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 090715 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 71610-027 | 71610-027-83 | 3600 TABLET in 1 BOTTLE (71610-027-83) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 48MG | ||||
Approval Date: | Apr 5, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 145MG | ||||
Approval Date: | Apr 5, 2012 | TE: | AB | RLD: | No |
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