Details for New Drug Application (NDA): 200264
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NDA 200264 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Labs Inc, Macleods Pharms Ltd, Micro Labs, Norvium Bioscience, Rising, Twi Pharms, and Yichang Humanwell, and is included in twelve NDAs. It is available from nine suppliers. Additional details are available on the FENOFIBRIC ACID profile page.
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.
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 200264
| Tradename: | FENOFIBRIC ACID |
| Applicant: | Impax Labs Inc |
| Ingredient: | choline fenofibrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200264
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 200264 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1324 | 0115-1324-10 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1324-10) |
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 200264 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-1325 | 0115-1325-10 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0115-1325-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 45MG FENOFIBRIC ACID | ||||
| Approval Date: | Sep 7, 2016 | 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: | Sep 7, 2016 | TE: | AB | RLD: | No | ||||
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