Details for New Drug Application (NDA): 210476
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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 210476
Tradename: | FENOFIBRATE |
Applicant: | Alembic |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210476
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 210476 | ANDA | Alembic Pharmaceuticals Limited | 46708-360 | 46708-360-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-360-30) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 210476 | ANDA | Alembic Pharmaceuticals Limited | 46708-360 | 46708-360-71 | 500 TABLET, FILM COATED in 1 BOTTLE (46708-360-71) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 48MG | ||||
Approval Date: | Aug 9, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 145MG | ||||
Approval Date: | Aug 9, 2019 | TE: | AB | RLD: | No |
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