Details for New Drug Application (NDA): 202252

NDA 202252 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, Rhodes Pharms, Rising, and Torrent, and is included in sixteen NDAs. It is available from seventeen suppliers. Additional details are available on the FENOFIBRATE (MICRONIZED) profile page.

The generic ingredient in FENOFIBRATE (MICRONIZED) 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 202252

Tradename:	FENOFIBRATE (MICRONIZED)
Applicant:	Apotex
Ingredient:	fenofibrate
Patents:	0

Pharmacology for NDA: 202252

Medical Subject Heading (MeSH) Categories for 202252

Hypolipidemic Agents

Suppliers and Packaging for NDA: 202252

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202252	ANDA	Apotex Corp.	60505-3120	60505-3120-1	100 CAPSULE in 1 BOTTLE (60505-3120-1)
FENOFIBRATE (MICRONIZED)	fenofibrate	CAPSULE;ORAL	202252	ANDA	Apotex Corp.	60505-3120	60505-3120-3	30 CAPSULE in 1 BOTTLE (60505-3120-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	43MG
Approval Date:	Jul 26, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	130MG
Approval Date:	Jul 26, 2013	TE:	AB	RLD:	No

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