Details for New Drug Application (NDA): 210469
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The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There are one hundred and two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 210469
Tradename: | FENOFIBRIC ACID |
Applicant: | Scinopharm Taiwan |
Ingredient: | choline fenofibrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 210469
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 210469 | ANDA | TWi Pharmaceuticals, Inc. | 24979-109 | 24979-109-07 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-109-07) |
FENOFIBRIC ACID | choline fenofibrate | CAPSULE, DELAYED RELEASE;ORAL | 210469 | ANDA | TWi Pharmaceuticals, Inc. | 24979-112 | 24979-112-07 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-112-07) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | EQ 45MG FENOFIBRIC ACID | ||||
Approval Date: | Jul 5, 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 5, 2019 | TE: | AB | RLD: | No |
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