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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 076520

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NDA 076520 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 076520

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

Pharmacology for NDA: 076520

Medical Subject Heading (MeSH) Categories for 076520

Hypolipidemic Agents

Suppliers and Packaging for NDA: 076520

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	076520	ANDA	Mylan Pharmaceuticals Inc.	0378-7100	0378-7100-77	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7100-77)
FENOFIBRATE	fenofibrate	TABLET;ORAL	076520	ANDA	Mylan Pharmaceuticals Inc.	0378-7101	0378-7101-77	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7101-77)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	54MG
Approval Date:	Oct 25, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	107MG
Approval Date:	Dec 29, 2005	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Oct 25, 2007	TE:	AB	RLD:	No

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