Details for New Drug Application (NDA): 207796

NDA 207796 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 207796

Tradename:	FENOFIBRIC ACID
Applicant:	Macleods Pharms Ltd
Ingredient:	choline fenofibrate
Patents:	0

Pharmacology for NDA: 207796

Suppliers and Packaging for NDA: 207796

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	207796	ANDA	Macleods Pharmaceuticals Limited	33342-294	33342-294-10	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-294-10)
FENOFIBRIC ACID	choline fenofibrate	CAPSULE, DELAYED RELEASE;ORAL	207796	ANDA	Macleods Pharmaceuticals Limited	33342-294	33342-294-12	10 BLISTER PACK in 1 CARTON (33342-294-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	EQ 45MG FENOFIBRIC ACID
Approval Date:	Feb 8, 2024	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:	Feb 8, 2024	TE:		RLD:	No

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