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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 076005

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NDA 076005 describes ECONAZOLE NITRATE, which is a drug marketed by Aurobindo Pharma Usa, Chartwell Rx, Encube, Padagis Israel, and Sun Pharma Canada, and is included in five NDAs. It is available from five suppliers. Additional details are available on the ECONAZOLE NITRATE profile page.

The generic ingredient in ECONAZOLE NITRATE is econazole nitrate. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.

Summary for 076005

Tradename:	ECONAZOLE NITRATE
Applicant:	Sun Pharma Canada
Ingredient:	econazole nitrate
Patents:	0

Pharmacology for NDA: 076005

Medical Subject Heading (MeSH) Categories for 076005

14-alpha Demethylase Inhibitors
Antifungal Agents

Suppliers and Packaging for NDA: 076005

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	076005	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1303	51672-1303-1	1 TUBE in 1 CARTON (51672-1303-1) / 15 g in 1 TUBE
ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	076005	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1303	51672-1303-2	1 TUBE in 1 CARTON (51672-1303-2) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Nov 26, 2002	TE:	AB	RLD:	No

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