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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 210469


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NDA 210469 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Aurobindo Pharma Ltd, Graviti Pharms, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, and Twi Pharms, and is included in nine 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. Twelve suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 210469
Tradename:FENOFIBRIC ACID
Applicant:Twi Pharms
Ingredient:choline fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 210469
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:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Jul 5, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Jul 5, 2019TE:ABRLD:No

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