Spectazole

NDA 18751, held by Alvogen. Econazole Nitrate.

As of Nov 13, 2026, NDA 18751 (Spectazole), held by Alvogen, was first approved by FDA on Dec 23, 1982, with 16 approved supplements and 0 published complete response letters.

First approved: Dec 23, 1982
Review: Standard
Supplements approved: 16
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Dec 23, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Spectazole1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · cream;topical	Econazole Nitrate	DiscontinuedReference drug

All 17 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Jan 21, 2020	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 7, 2017	Supplement 24Manufacturing	Approved	Label
Mar 28, 2014	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 11, 2001	Supplement 19Manufacturing · Standard review	Approved	None posted
Apr 4, 2001	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 20, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Jul 23, 1998	Supplement 16Manufacturing · Standard review	Approved	None posted
Nov 17, 1995	Supplement 12Manufacturing · Standard review	Approved	None posted
Feb 24, 1995	Supplement 11Labeling · Standard review	Approved	None posted
Sep 10, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 25, 1990	Supplement 6Labeling	Approved	None posted
Mar 9, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 18, 1986	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 28, 1985	Supplement 4Manufacturing · Standard review	Approved	None posted
May 22, 1985	Supplement 1Labeling	Approved	None posted
Jan 8, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 23, 1982	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18751
Drugs@FDA: Overview at FDA
Company: Alvogen

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters