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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 018751

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NDA 018751 describes SPECTAZOLE, which is a drug marketed by Alvogen and is included in one NDA. Additional details are available on the SPECTAZOLE profile page.

The generic ingredient in SPECTAZOLE 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 018751

Tradename:	SPECTAZOLE
Applicant:	Alvogen
Ingredient:	econazole nitrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 018751

14-alpha Demethylase Inhibitors
Antifungal Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 23, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 018751

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alvogen	SPECTAZOLE	econazole nitrate	CREAM;TOPICAL	018751-001	Dec 23, 1982	3,717,655	⤷ Get Started Free
Alvogen	SPECTAZOLE	econazole nitrate	CREAM;TOPICAL	018751-001	Dec 23, 1982	3,839,574	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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