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Generated: August 20, 2017

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 Alembic Pharms Ltd, Mylan Pharms Inc, Actavis Elizabeth, Lupin Ltd, Impax Labs Inc, and Anchen Pharms, 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 ninety-nine 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 NDA: 201573

Tradename:
1
Applicant:
1
Ingredient:
1
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 10370-209-09 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (10370-209-09)
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)

Summary for product number 001

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

Summary 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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