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Generated: November 15, 2018

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Details for New Drug Application (NDA): 200913

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NDA 200913 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Impax Labs Inc, Lupin Ltd, and Mylan Pharms Inc, and is included in six NDAs. It is available from seven 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. Ten suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.
Summary for 200913
Tradename:FENOFIBRIC ACID
Applicant:Mylan Pharms Inc
Ingredient:choline fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200913
Suppliers and Packaging for NDA: 200913
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200913 ANDA Mylan Pharmaceuticals Inc. 0378-2589 0378-2589-77 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2589-77)
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200913 ANDA Mylan Pharmaceuticals Inc. 0378-2590 0378-2590-77 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2590-77)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Mar 25, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Mar 25, 2013TE:ABRLD:No

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