Details for New Drug Application (NDA): 090856
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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 090856
Tradename: | FENOFIBRATE |
Applicant: | Lupin Ltd |
Ingredient: | fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 090856
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRATE | fenofibrate | TABLET;ORAL | 090856 | ANDA | AvPAK | 50268-338 | 50268-338-12 | 20 BLISTER PACK in 1 BOX (50268-338-12) / 1 TABLET in 1 BLISTER PACK (50268-338-11) |
FENOFIBRATE | fenofibrate | TABLET;ORAL | 090856 | ANDA | American Health Packaging | 60687-618 | 60687-618-21 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-618-21) / 1 TABLET in 1 BLISTER PACK (60687-618-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 48MG | ||||
Approval Date: | Dec 23, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 145MG | ||||
Approval Date: | Dec 23, 2011 | TE: | AB | RLD: | No |
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