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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 076433

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NDA 076433 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, Graviti Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Sun Pharm, Valeant Pharms North, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, Reyoung, Rising, Torrent, and Youngtech Pharms Inc, and is included in forty-five NDAs. It is available from forty-one 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-one suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 076433

Tradename:	FENOFIBRATE
Applicant:	Rhodes Pharms
Ingredient:	fenofibrate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 076433

Medical Subject Heading (MeSH) Categories for 076433

Hypolipidemic Agents

Suppliers and Packaging for NDA: 076433

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	076433	ANDA	Rhodes Pharmaceuticals L.P.	42858-454	42858-454-45	90 TABLET, FILM COATED in 1 BOTTLE (42858-454-45)
FENOFIBRATE	fenofibrate	TABLET;ORAL	076433	ANDA	Rhodes Pharmaceuticals L.P.	42858-660	42858-660-45	90 TABLET, FILM COATED in 1 BOTTLE (42858-660-45)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	54MG
Approval Date:	May 13, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	May 13, 2005	TE:	AB	RLD:	No

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