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Last Updated: April 22, 2025

Details for New Drug Application (NDA): 205118

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NDA 205118 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, Macleods Pharms 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-seven 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 205118

Tradename:	FENOFIBRATE
Applicant:	Aurobindo Pharma
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 205118

Medical Subject Heading (MeSH) Categories for 205118

Hypolipidemic Agents

Suppliers and Packaging for NDA: 205118

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	205118	ANDA	A-S Medication Solutions	50090-3887	50090-3887-0	90 TABLET, COATED in 1 BOTTLE (50090-3887-0)
FENOFIBRATE	fenofibrate	TABLET;ORAL	205118	ANDA	Aurobindo Pharma Limited	65862-768	65862-768-01	100 TABLET, COATED in 1 BOTTLE (65862-768-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	48MG
Approval Date:	May 5, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	145MG
Approval Date:	May 5, 2016	TE:	AB	RLD:	No

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