Details for New Drug Application (NDA): 213450

NDA 213450 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 ten 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 213450

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

Pharmacology for NDA: 213450

Suppliers and Packaging for NDA: 213450

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	213450	ANDA	Micro Labs Limited	42571-347	42571-347-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-347-30)
FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	213450	ANDA	Micro Labs Limited	42571-347	42571-347-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42571-347-90)

Profile for product number 001

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

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