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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 218548

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NDA 218548 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 218548

Tradename:	FENOFIBRATE
Applicant:	Yichang Humanwell
Ingredient:	fenofibrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 218548

Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	54MG
Approval Date:	Apr 24, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Apr 24, 2024	TE:	AB	RLD:	No

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