← FDA DRUG APPROVALS

FDA NDA · NDA020670

MONISTAT 3 COMBINATION PACK 3 OVULE INSERTS

miconazole nitrate

Sponsor: MEDTECH PRODUCTS

APPLICATION
NDA020670
TYPE
NDA
ORIGINAL APPROVAL
1996-04-16
LATEST ACTION
2023-11-17
ROUTE
TOPICAL, VAGINAL, TOPICAL, VAGINAL
DOSAGE FORM
CREAM, SUPPOSITORY
MARKETING STATUS
Over-the-counter

Products

MONISTAT 3 COMBINATION PACK · ReferenceOver-the-counter
MICONAZOLE NITRATE 2%,200MG · CREAM, SUPPOSITORY · TOPICAL, VAGINAL

Approval history

2023-11-17Labeling · Supplement 41 · standard — Letter ↗AP
2020-07-22Manufacturing (CMC) · Supplement 36 — Letter ↗AP
2020-01-28Labeling · Supplement 35 · standard — Label ↗AP
2016-01-21Manufacturing (CMC) · Supplement 29 · standardAP
2015-11-20Manufacturing (CMC) · Supplement 28 · standardAP
2014-02-11Manufacturing (CMC) · Supplement 24 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 22 · standardAP
2013-02-06Manufacturing (CMC) · Supplement 21 · standardAP
2007-03-16Manufacturing (CMC) · Supplement 14 — Review ↗AP
2003-01-09Labeling · Supplement 11 · standard — Letter ↗AP
2002-10-28Manufacturing (CMC) · Supplement 10 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 9 · standard — Review ↗AP
2000-01-20Manufacturing (CMC) · Supplement 7 · standardAP
1999-10-04Manufacturing (CMC) · Supplement 5 · standardAP
1999-03-26Manufacturing (CMC) · Supplement 4 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 3 · standardAP
1997-03-21Manufacturing (CMC) · Supplement 2 · standardAP
1996-08-15Manufacturing (CMC) · Supplement 1 · standardAP
1996-04-16Type 8 - Partial Rx to OTC Switch · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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.

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