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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204598

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NDA 204598 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic, Amneal, Aurobindo Pharma, Bausch, Bostal, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Rising, Sun Pharm, Yichang Humanwell, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, Pharmobedient, Reyoung, and Torrent, and is included in forty-seven NDAs. It is available from forty-seven suppliers. Additional details are available on the FENOFIBRATE profile page.

The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 204598

Tradename:	FENOFIBRATE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 204598

Medical Subject Heading (MeSH) Categories for 204598

Hypolipidemic Agents

Suppliers and Packaging for NDA: 204598

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	204598	ANDA	Camber Pharmaceuticals, Inc.	31722-595	31722-595-30	30 TABLET, FILM COATED in 1 BOTTLE (31722-595-30)
FENOFIBRATE	fenofibrate	TABLET;ORAL	204598	ANDA	Camber Pharmaceuticals, Inc.	31722-595	31722-595-31	100 TABLET, FILM COATED in 1 BLISTER PACK (31722-595-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	48MG
Approval Date:	Jul 12, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	145MG
Approval Date:	Jul 12, 2016	TE:	AB	RLD:	No

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