Last Updated: November 8, 2026

Details for New Drug Application (NDA): 213450

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NDA 213450 describes FENOFIBRIC ACID, which is a drug marketed by Actavis Elizabeth, Alembic, Aurobindo Pharma Ltd, Chartwell Rx, Impax Labs Inc, Macleods Pharms, Micro Labs, Ph Health, Pharmobedient, Rising, Twi Pharms, and Yichang Humanwell, and is included in twelve NDAs. It is available from six suppliers. Additional details are available on the FENOFIBRIC ACID profile page.

The generic ingredient in FENOFIBRIC ACID is choline fenofibrate. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the choline fenofibrate profile page.

Summary for 213450

Tradename:	FENOFIBRIC ACID
Applicant:	Micro Labs
Ingredient:	choline fenofibrate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 45MG FENOFIBRIC ACID
Approval Date:	Jun 16, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 135MG FENOFIBRIC ACID
Approval Date:	Jun 16, 2020	TE:		RLD:	No

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