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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 210138

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NDA 210138 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 210138

Tradename:	FENOFIBRATE
Applicant:	Ajanta Pharma Ltd
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 210138

Medical Subject Heading (MeSH) Categories for 210138

Hypolipidemic Agents

Suppliers and Packaging for NDA: 210138

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE	fenofibrate	TABLET;ORAL	210138	ANDA	NCS HealthCare of KY, Inc dba Vangard Labs	0615-8270	0615-8270-39	30 TABLET in 1 BLISTER PACK (0615-8270-39)
FENOFIBRATE	fenofibrate	TABLET;ORAL	210138	ANDA	Ajanta Pharma USA Inc.	27241-116	27241-116-03	90 TABLET in 1 BOTTLE (27241-116-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	54MG
Approval Date:	Jul 23, 2018	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Jul 23, 2018	TE:	AB	RLD:	No

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