Last Updated: August 3, 2026

Details for New Drug Application (NDA): 075753

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NDA 075753 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, Ingenus Pharms Llc, Invagen Pharms, Pharmobedient, Reyoung, Rhodes Pharms, Rising, Sun Pharm Inds Ltd, and Torrent, and is included in seventeen 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-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

Summary for 075753

Tradename:	FENOFIBRATE (MICRONIZED)
Applicant:	Rhodes Pharms
Ingredient:	fenofibrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 075753

Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	67MG
Approval Date:	Sep 3, 2002	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	134MG
Approval Date:	Apr 9, 2002	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Apr 9, 2002	TE:	AB	RLD:	No

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