Last Updated: July 21, 2026

Details for New Drug Application (NDA): 076574

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NDA 076574 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 six 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. Eight suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.

Summary for 076574

Tradename:	ECONAZOLE NITRATE
Applicant:	Encube
Ingredient:	econazole nitrate
Patents:	0

Pharmacology for NDA: 076574

Medical Subject Heading (MeSH) Categories for 076574

14-alpha Demethylase Inhibitors
Antifungal Agents

Suppliers and Packaging for NDA: 076574

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	076574	ANDA	Encube Ethicals, Inc.	21922-111	21922-111-04	1 TUBE in 1 CARTON (21922-111-04) / 15 g in 1 TUBE
ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	076574	ANDA	Encube Ethicals, Inc.	21922-111	21922-111-05	1 TUBE in 1 CARTON (21922-111-05) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Dec 17, 2004	TE:		RLD:	No

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