Miconazole Nitrate

ANDA 74760, held by Perrigo. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 74760 (Miconazole Nitrate), held by Perrigo, was first approved by FDA on May 15, 1997, with 7 approved supplements and 0 published complete response letters.

First approved: May 15, 1997
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

treats vaginal yeast infections
relieves external itching and irritation due to a vaginal yeast infection

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 15, 1997	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miconazole Nitrate2% · cream;vaginal	Miconazole Nitrate	OTC

All 8 submissions, including labeling and manufacturing supplements


Aug 21, 2017	Supplement 37Labeling · Standard review	Approved	None posted
Apr 14, 2005	Supplement 15Labeling	Approved	None posted
Aug 17, 2004	Supplement 9Labeling	Approved	None posted
Jan 30, 2002	Supplement 4Labeling	Approved	None posted
Jan 30, 2002	Supplement 5Labeling	Approved	None posted
Jun 8, 1999	Supplement 3Manufacturing	Approved	None posted
Sep 25, 1998	Supplement 2Manufacturing	Approved	None posted
May 15, 1997	Original application	Approved	Review

Identifiers

Application: ANDA 74760
Drugs@FDA: Overview at FDA
Company: Perrigo

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