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Last Updated: November 14, 2025

Details for New Drug Application (NDA): 072191

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NDA 072191 describes CLOFIBRATE, which is a drug marketed by Banner Pharmacaps, Sandoz, Teva, Usl Pharma, and Watson Labs, and is included in five NDAs. Additional details are available on the CLOFIBRATE profile page.

The generic ingredient in CLOFIBRATE is clofibrate. There are four drug master file entries for this compound. Additional details are available on the clofibrate profile page.

Summary for 072191

Tradename:	CLOFIBRATE
Applicant:	Sandoz
Ingredient:	clofibrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 072191

Anticholesteremic Agents
Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG
Approval Date:	May 2, 1988	TE:		RLD:	No

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