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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 074615

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NDA 074615 describes GEMFIBROZIL, which is a drug marketed by Natco, Purepac Pharm, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Chartwell Rx, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Norvium Bioscience, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in twenty NDAs. It is available from thirty-three suppliers. Additional details are available on the GEMFIBROZIL profile page.

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

Summary for 074615

Tradename:	GEMFIBROZIL
Applicant:	Chartwell Rx
Ingredient:	gemfibrozil
Patents:	0

Medical Subject Heading (MeSH) Categories for 074615

Cytochrome P-450 CYP2C8 Inhibitors
Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Sep 29, 1995	TE:		RLD:	No

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