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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 210606

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NDA 210606 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 210606

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

Pharmacology for NDA: 210606

Medical Subject Heading (MeSH) Categories for 210606

Hypolipidemic Agents

Suppliers and Packaging for NDA: 210606

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	210606	ANDA	Laurus Labs Limited	42385-935	42385-935-05	500 TABLET, FILM COATED in 1 BOTTLE (42385-935-05)
FENOFIBRATE	fenofibrate	TABLET;ORAL	210606	ANDA	Laurus Labs Limited	42385-935	42385-935-11	1000 TABLET, FILM COATED in 1 BOTTLE (42385-935-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	54MG
Approval Date:	Aug 17, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Aug 17, 2018	TE:	AB	RLD:	No

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