Last Updated: June 24, 2026

Details for New Drug Application (NDA): 090715

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NDA 090715 describes FENOFIBRATE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Amneal, Aurobindo Pharma, Bausch, Bostal, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Impax Labs, Lupin, Lupin Ltd, Macleods Pharms Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Rising, Sun Pharm, Sun Pharm Inds Ltd, 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-eight 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 090715

Tradename:	FENOFIBRATE
Applicant:	Bausch
Ingredient:	fenofibrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 090715

Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	48MG
Approval Date:	Apr 5, 2012	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	145MG
Approval Date:	Apr 5, 2012	TE:		RLD:	No

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