Miconazole Nitrate

ANDA 79114, held by Perrigo R And D. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 79114 (Miconazole Nitrate), held by Perrigo R And D, was first approved by FDA on Jun 2, 2010, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 2, 2010
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Jun 2, 2010	Original application	Approved	None posted

Products

2 strengths and forms


Miconazole Nitrate2%,1.2GM · cream, insert;topical, vaginal	Miconazole Nitrate	OTC
Miconazole Nitrate2% · cream; topical, vaginal	Miconazole Nitrate	OTC

All 3 submissions, including labeling and manufacturing supplements


Jun 11, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Aug 25, 2017	Supplement 6Labeling · Standard review	Approved	None posted
Jun 2, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 79114
Drugs@FDA: Overview at FDA
Company: Perrigo R&D

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