Miconazole 3 Combination Pack

ANDA 76357, held by Perrigo. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 76357 (Miconazole 3 Combination Pack), held by Perrigo, was first approved by FDA on Mar 30, 2004, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 30, 2004
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
Mar 30, 2004	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miconazole 3 Combination Pack2%,4% · cream;topical, vaginal	Miconazole Nitrate	OTC

All 3 submissions, including labeling and manufacturing supplements


Aug 21, 2017	Supplement 30Labeling · Standard review	Approved	None posted
Apr 12, 2005	Supplement 5Labeling	Approved	None posted
Mar 30, 2004	Original application	Approved	None posted

Identifiers

Application: ANDA 76357
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