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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 Mylan Pharms Inc, Actavis Elizabeth, Lupin Ltd, Impax Labs Inc, and Anchen Pharms, and is included in five NDAs. It is available from five 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. Nine suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.

Summary for NDA: 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)

Summary for product number 001

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

Summary 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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