← FDA DRUG APPROVALS

FDA NDA · NDA020827

MONISTAT 3 3 DAY

miconazole nitrate

Sponsor: MEDTECH PRODUCTS

APPLICATION
NDA020827
TYPE
NDA
ORIGINAL APPROVAL
1998-03-30
LATEST ACTION
2021-09-15
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

MONISTAT 3 · ReferenceOver-the-counter
MICONAZOLE NITRATE 4% · CREAM · VAGINAL

Approval history

2021-09-15Manufacturing (CMC) · Supplement 33 — Letter ↗AP
2020-01-28Labeling · Supplement 31 · standard — Label ↗AP
2014-03-10Manufacturing (CMC) · Supplement 25 · standardAP
2014-02-27Manufacturing (CMC) · Supplement 24 · standardAP
2014-02-11Manufacturing (CMC) · Supplement 23 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 21 · standardAP
2013-01-29Manufacturing (CMC) · Supplement 20 · standardAP
2009-10-02Manufacturing (CMC) · Supplement 14 — Label ↗AP
2008-09-05Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2002-10-28Manufacturing (CMC) · Supplement 10 · standardAP
2002-08-07Labeling · Supplement 6 · standard — Letter ↗AP
2002-04-10Manufacturing (CMC) · Supplement 9 · standardAP
2001-11-28Manufacturing (CMC) · Supplement 8 · standardAP
2000-10-17Manufacturing (CMC) · Supplement 7 · standardAP
1999-03-26Manufacturing (CMC) · Supplement 4 · standardAP
1998-10-30Manufacturing (CMC) · Supplement 3 · standardAP
1998-10-06Manufacturing (CMC) · Supplement 1 · standardAP
1998-07-27Manufacturing (CMC) · Supplement 2 · standardAP
1998-03-30Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →