M-Zole 7 Dual Pack

ANDA 74586, held by Actavis Mid Atlantic. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 74586 (M-Zole 7 Dual Pack), held by Actavis Mid Atlantic, was first approved by FDA on Jul 17, 1997, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 17, 1997
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Jul 17, 1997	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
M-Zole 7 Dual Pack2%,100MG · cream, suppository;topical, vaginal	Miconazole Nitrate	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Nov 21, 2002	Supplement 6Labeling	Approved	None posted
Jan 8, 2002	Supplement 5Manufacturing	Approved	None posted
Dec 29, 2000	Supplement 4Manufacturing	Approved	None posted
Feb 9, 2000	Supplement 3Labeling	Approved	None posted
Apr 30, 1999	Supplement 2Manufacturing	Approved	None posted
Oct 1, 1998	Supplement 1Labeling	Approved	None posted
Jul 17, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74586
Drugs@FDA: Overview at FDA
Company: Actavis Mid Atlantic LLC

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