Last Updated: November 13, 2026

Details for New Drug Application (NDA): 210364

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NDA 210364 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.

Summary for 210364

Tradename:	ECONAZOLE NITRATE
Applicant:	Aurobindo Pharma Usa
Ingredient:	econazole nitrate
Patents:	0

Pharmacology for NDA: 210364

Medical Subject Heading (MeSH) Categories for 210364

14-alpha Demethylase Inhibitors
Antifungal Agents

Suppliers and Packaging for NDA: 210364

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	210364	ANDA	Aurobindo Pharma Limited	59651-945	59651-945-14	1 TUBE in 1 CARTON (59651-945-14) / 15 g in 1 TUBE
ECONAZOLE NITRATE	econazole nitrate	CREAM;TOPICAL	210364	ANDA	Aurobindo Pharma Limited	59651-945	59651-945-30	1 TUBE in 1 CARTON (59651-945-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	1%
Approval Date:	Apr 18, 2018	TE:	AB	RLD:	No

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