Miconazole Nitrate

ANDA 74444, held by Sun Pharma Canada. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 74444 (Miconazole Nitrate), held by Sun Pharma Canada, was first approved by FDA on Jan 13, 1997, with 10 approved supplements and 0 published complete response letters.

First approved: Jan 13, 1997
Supplements approved: 10
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 11 submissions below

Date	Submission	Status	Documents
Jan 13, 1997	Original application	Approved	None posted

Products

1 strengths and forms

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

All 11 submissions, including labeling and manufacturing supplements


Aug 29, 2025	Supplement 23Manufacturing	Approved	None posted
Oct 5, 2006	Supplement 12Labeling	Approved	None posted
Apr 8, 2005	Supplement 8Labeling	Approved	None posted
Nov 27, 2002	Supplement 7Manufacturing	Approved	None posted
Aug 16, 1999	Supplement 6Manufacturing	Approved	None posted
Jan 28, 1998	Supplement 5Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 1Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 2Manufacturing	Approved	None posted
Dec 5, 1997	Supplement 4Manufacturing	Approved	None posted
Aug 6, 1997	Supplement 3Manufacturing	Approved	None posted
Jan 13, 1997	Original application	Approved	None posted

Identifiers

Application: ANDA 74444
Drugs@FDA: Overview at FDA
Company: Sun Pharma Canada

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