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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 212598


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NDA 212598 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic, Anchen Pharms, Aurobindo Pharma Ltd, Graviti Pharms, Impax Labs Inc, Lupin Ltd, Micro Labs, Mylan Pharms Inc, Scinopharm Taiwan, and Yichang Humanwell, and is included in eleven 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. Eleven suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 212598
Tradename:FENOFIBRIC ACID
Applicant:Aurobindo Pharma Ltd
Ingredient:choline fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 212598
Suppliers and Packaging for NDA: 212598
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 212598 ANDA Aurobindo Pharma Limited 59651-216 59651-216-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-216-90)
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 212598 ANDA Aurobindo Pharma Limited 59651-217 59651-217-90 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-217-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Jul 25, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Jul 25, 2019TE:ABRLD:No

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