Last Updated: May 3, 2026

Details for New Drug Application (NDA): 075034

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NDA 075034 describes GEMFIBROZIL, which is a drug marketed by Natco, Purepac Pharm, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Chartwell Rx, Epic Pharma Llc, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Pharmobedient, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in twenty NDAs. It is available from twenty-nine suppliers. Additional details are available on the GEMFIBROZIL profile page.

The generic ingredient in GEMFIBROZIL is gemfibrozil. Thirty suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.

Summary for 075034

Tradename:	GEMFIBROZIL
Applicant:	Apotex
Ingredient:	gemfibrozil
Patents:	0

Medical Subject Heading (MeSH) Categories for 075034

Cytochrome P-450 CYP2C8 Inhibitors
Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Jul 20, 1998	TE:		RLD:	No

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