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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200750

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NDA 200750 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Aurobindo Pharma Ltd, Graviti Pharms, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, and Twi Pharms, and is included in nine NDAs. It is available from eight 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 200750
Tradename:FENOFIBRIC ACID
Applicant:Lupin Ltd
Ingredient:choline fenofibrate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200750
Suppliers and Packaging for NDA: 200750
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200750 ANDA A-S Medication Solutions 50090-4373 50090-4373-0 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4373-0)
FENOFIBRIC ACID choline fenofibrate CAPSULE, DELAYED RELEASE;ORAL 200750 ANDA Lupin Pharmaceuticals, Inc. 68180-128 68180-128-01 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 45MG FENOFIBRIC ACID
Approval Date:Dec 4, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 135MG FENOFIBRIC ACID
Approval Date:Dec 4, 2013TE:ABRLD:No

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