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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 208709

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NDA 208709 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 208709

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

Pharmacology for NDA: 208709

Medical Subject Heading (MeSH) Categories for 208709

Hypolipidemic Agents

Suppliers and Packaging for NDA: 208709

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	208709	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8530	0615-8530-39	30 TABLET in 1 BLISTER PACK (0615-8530-39)
FENOFIBRATE	fenofibrate	TABLET;ORAL	208709	ANDA	Major Pharmaceuticals	0904-7161	0904-7161-04	30 BLISTER PACK in 1 CARTON (0904-7161-04) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	48MG
Approval Date:	Dec 15, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	145MG
Approval Date:	Dec 15, 2016	TE:	AB	RLD:	No

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