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Last Updated: December 28, 2024

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, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Labs Inc, Macleods Pharms Ltd, Micro Labs, Norvium Bioscience, Rising, Twi Pharms, and Yichang Humanwell, and is included in twelve NDAs. It is available from nine 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 200750

Tradename:	FENOFIBRIC ACID
Applicant:	Chartwell Rx
Ingredient:	choline fenofibrate
Patents:	0

Pharmacology for NDA: 200750

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 45MG FENOFIBRIC ACID
Approval Date:	Dec 4, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 135MG FENOFIBRIC ACID
Approval Date:	Dec 4, 2013	TE:	AB	RLD:	No

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