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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 204189

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NDA 204189 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 204189

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

Pharmacology for NDA: 204189

Mechanism of Action	Peroxisome Proliferator-activated Receptor alpha Agonists

Medical Subject Heading (MeSH) Categories for 204189

Cytochrome P-450 CYP2C8 Inhibitors
Hypolipidemic Agents

Suppliers and Packaging for NDA: 204189

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GEMFIBROZIL	gemfibrozil	TABLET;ORAL	204189	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-553	68382-553-01	100 TABLET in 1 BOTTLE (68382-553-01)
GEMFIBROZIL	gemfibrozil	TABLET;ORAL	204189	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-553	68382-553-05	500 TABLET in 1 BOTTLE (68382-553-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Aug 28, 2018	TE:		RLD:	No

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