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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201573

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NDA 201573 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 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 201573
Tradename:FENOFIBRIC ACID
Applicant:Anchen Pharms
Ingredient:choline fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201573
Suppliers and Packaging for NDA: 201573
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 201573 ANDA Par Pharmaceutical, Inc. 10370-209 10370-209-10 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (10370-209-10)
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 201573 ANDA Par Pharmaceutical, Inc. 10370-209 10370-209-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (10370-209-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Jul 18, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Jul 18, 2013TE:ABRLD:No

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