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Last Updated: December 26, 2024

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, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Rising, Sun Pharm, Valeant Pharms North, Yichang Humanwell, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, and Torrent, and is included in forty-six NDAs. It is available from forty-five 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-three 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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