Miconazole Nitrate

ANDA 91366, held by Perrigo R And D. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 91366 (Miconazole Nitrate), held by Perrigo R And D, was first approved by FDA on Jan 15, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 15, 2010
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses

treats vaginal yeast infections

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jan 15, 2010	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miconazole Nitrate4% · cream;vaginal	Miconazole Nitrate	OTC

All 2 submissions, including labeling and manufacturing supplements


Aug 21, 2017	Supplement 1Labeling · Standard review	Approved	None posted
Jan 15, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 91366
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