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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090715

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NDA 090715 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-four 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:	Valeant Pharms North
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 090715

Medical Subject Heading (MeSH) Categories for 090715

Hypolipidemic Agents

Suppliers and Packaging for NDA: 090715

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	090715	ANDA	Proficient Rx LP	71205-050	71205-050-90	90 TABLET in 1 BOTTLE (71205-050-90)
FENOFIBRATE	fenofibrate	TABLET;ORAL	090715	ANDA	Aphena Pharma Solutions - Tennessee, LLC	71610-027	71610-027-83	3600 TABLET in 1 BOTTLE (71610-027-83)

Profile for product number 001

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

Profile for product number 002

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

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