DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 200750
The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 200750
Tradename: | FENOFIBRIC ACID |
Applicant: | Lupin Ltd |
Ingredient: | choline fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 200750
Ingredient-type | PPAR alpha |
Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Suppliers and Packaging for NDA: 200750
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 200750 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-128 | N | 68180-128-02 |
FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 200750 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-128 | N | 68180-128-09 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 45MG FENOFIBRIC ACID | ||||
Approval Date: | Dec 4, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 135MG FENOFIBRIC ACID | ||||
Approval Date: | Dec 4, 2013 | TE: | AB | RLD: | No |
Complete Access Available with Subscription