Details for New Drug Application (NDA): 204019
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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 204019
Tradename: | FENOFIBRATE |
Applicant: | Lupin Ltd |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204019
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 204019 | ANDA | Major Pharmaceuticals | 0904-7128 | 0904-7128-04 | 30 BLISTER PACK in 1 CARTON (0904-7128-04) / 1 TABLET in 1 BLISTER PACK |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 204019 | ANDA | A-S Medication Solutions | 50090-5854 | 50090-5854-0 | 30 TABLET in 1 BOTTLE (50090-5854-0) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 54MG | ||||
Approval Date: | Aug 17, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 160MG | ||||
Approval Date: | Aug 17, 2015 | TE: | AB | RLD: | No |
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