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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078599

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NDA 078599 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-eight suppliers. Additional details are available on the GEMFIBROZIL profile page.

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

Summary for 078599

Tradename:	GEMFIBROZIL
Applicant:	Hikma Pharms
Ingredient:	gemfibrozil
Patents:	0

Medical Subject Heading (MeSH) Categories for 078599

Cytochrome P-450 CYP2C8 Inhibitors
Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Aug 16, 2010	TE:		RLD:	No

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