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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204475

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NDA 204475 describes FENOFIBRATE, which is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic, Amneal, Aurobindo Pharma, Bausch, Bostal, 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, Yichang Humanwell, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, Pharmobedient, Reyoung, and Torrent, and is included in forty-seven NDAs. It is available from forty-seven 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-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 204475

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

Pharmacology for NDA: 204475

Medical Subject Heading (MeSH) Categories for 204475

Hypolipidemic Agents

Suppliers and Packaging for NDA: 204475

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	204475	ANDA	Mylan Pharmaceuticals Inc.	0378-4390	0378-4390-77	90 TABLET in 1 BOTTLE, PLASTIC (0378-4390-77)
FENOFIBRATE	fenofibrate	TABLET;ORAL	204475	ANDA	Mylan Pharmaceuticals Inc.	0378-4391	0378-4391-77	90 TABLET in 1 BOTTLE, PLASTIC (0378-4391-77)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jun 23, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	120MG
Approval Date:	Jun 23, 2016	TE:	AB	RLD:	No

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