Miconazole Nitrate

Treats vulvovaginal candidiasis (moniliasis). ANDA 73508, held by Actavis Pharma. Miconazole Nitrate.

As of Nov 15, 2026, ANDA 73508 (Miconazole Nitrate), held by Actavis Pharma, was first approved by FDA on Nov 19, 1993, with 12 approved supplements and 0 published complete response letters.

First approved: Nov 19, 1993
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Miconazole Nitrate Vaginal Suppositories USP, 200 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). Effectiveness in pregnancy has not been established. As miconazole nitrate is effective only for candidal vulvovaginitis, the diagnosis should be confirmed by KOH smear and/or cultures. Other pathogens commonly associated with vulvovaginitis ( Trichomonas and Haemophilus vaginalis [Gardnerella] ) should be ruled out by appropriate laboratory methods.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Nov 19, 1993	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Miconazole Nitrate200MG · suppository;vaginal	Miconazole Nitrate	Rx

All 13 submissions, including labeling and manufacturing supplements


Jul 9, 2002	Supplement 15Manufacturing	Approved	None posted
Jan 8, 2002	Supplement 14Manufacturing	Approved	None posted
Dec 29, 2000	Supplement 13Manufacturing	Approved	None posted
Jan 9, 1998	Supplement 12Manufacturing	Approved	None posted
Oct 11, 1996	Supplement 7Manufacturing	Approved	None posted
Jul 24, 1996	Supplement 4Manufacturing	Approved	None posted
Jul 24, 1996	Supplement 5Manufacturing	Approved	None posted
Jul 24, 1996	Supplement 6Manufacturing	Approved	None posted
Jul 24, 1996	Supplement 9Manufacturing	Approved	None posted
Jun 28, 1996	Supplement 8Manufacturing	Approved	None posted
May 15, 1995	Supplement 2Manufacturing	Approved	None posted
Jan 30, 1995	Supplement 1Manufacturing	Approved	None posted
Nov 19, 1993	Original application	Approved	None posted

Identifiers

Application: ANDA 73508
Drugs@FDA: Overview at FDA
Company: Actavis Pharmaceuticals

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