Details for New Drug Application (NDA): 208705
NDA 208705 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic, Aurobindo Pharma Ltd, Chartwell Rx, Impax Labs Inc, Macleods Pharms, Micro Labs, Ph Health, Pharmobedient, Rising, Twi Pharms, and Yichang Humanwell, and is included in twelve NDAs. It is available from six suppliers. Additional details are available on the FENOFIBRIC ACID profile page.
The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There is one drug master file entry for this compound. Six 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 208705
| Tradename: | FENOFIBRIC ACID |
| Applicant: | Alembic |
| Ingredient: | choline fenofibrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208705
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 208705 | ANDA | Alembic Pharmaceuticals Limited | 46708-244 | 46708-244-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-30) |
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 208705 | ANDA | Alembic Pharmaceuticals Limited | 46708-244 | 46708-244-90 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-244-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 45MG FENOFIBRIC ACID | ||||
| Approval Date: | May 12, 2017 | 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: | May 12, 2017 | TE: | AB | RLD: | No | ||||
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