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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 207564

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NDA 207564 describes FENOFIBRATE (MICRONIZED), which is a drug marketed by Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Chartwell Rx, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Novast Labs, Pharmobedient, 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-six suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 207564

Tradename:	FENOFIBRATE (MICRONIZED)
Applicant:	Novast Labs
Ingredient:	fenofibrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 207564

Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	67MG
Approval Date:	Apr 19, 2019	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	134MG
Approval Date:	Apr 19, 2019	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Apr 19, 2019	TE:		RLD:	No

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