Details for New Drug Application (NDA): 211626
NDA 211626 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 211626
| Tradename: | FENOFIBRIC ACID |
| Applicant: | Rising |
| Ingredient: | choline fenofibrate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211626
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 211626 | ANDA | Leading Pharma, LLC | 69315-281 | 69315-281-09 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69315-281-09) |
| FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 211626 | ANDA | Leading Pharma, LLC | 69315-282 | 69315-282-09 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69315-282-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 45MG FENOFIBRIC ACID | ||||
| Approval Date: | Jul 18, 2019 | 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: | Jul 18, 2019 | TE: | AB | RLD: | No | ||||
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