← FDA DRUG APPROVALS

FDA NDA · NDA017450

MONISTAT 7 7-DAY DISPOSABLE APPLICATORS

miconazole nitrate

Sponsor: MEDTECH PRODUCTS

APPLICATION
NDA017450
TYPE
NDA
ORIGINAL APPROVAL
1974-01-30
LATEST ACTION
2020-07-22
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

MONISTAT 7 · ReferenceOver-the-counter
MICONAZOLE NITRATE 2% · CREAM · VAGINAL

Approval history

2020-07-22Manufacturing (CMC) · Supplement 75 — Letter ↗AP
2020-01-28Labeling · Supplement 73 · standard — Label ↗AP
2015-08-10Manufacturing (CMC) · Supplement 68 · priorityAP
2014-03-10Manufacturing (CMC) · Supplement 67 · priorityAP
2014-02-27Manufacturing (CMC) · Supplement 66 · priorityAP
2013-08-13Manufacturing (CMC) · Supplement 64 · priorityAP
2013-07-10Manufacturing (CMC) · Supplement 63 · priorityAP
2013-01-29Manufacturing (CMC) · Supplement 62 · priorityAP
2009-11-05Manufacturing (CMC) · Supplement 56 — Label ↗AP
2008-08-21Manufacturing (CMC) · Supplement 55 · priority — Label ↗AP
2002-10-28Manufacturing (CMC) · Supplement 51 · priorityAP
2002-08-07Manufacturing (CMC) · Supplement 52 · priority — Letter ↗AP
2002-04-10Manufacturing (CMC) · Supplement 50 · priorityAP
2001-05-16Manufacturing (CMC) · Supplement 49 · priorityAP
1999-10-04Manufacturing (CMC) · Supplement 47 · priorityAP
1999-02-04Manufacturing (CMC) · Supplement 46 · priorityAP
1999-02-03Manufacturing (CMC) · Supplement 45 · priorityAP
1998-03-17Manufacturing (CMC) · Supplement 44 · priorityAP
1997-03-21Manufacturing (CMC) · Supplement 43 · priorityAP
1995-03-06Manufacturing (CMC) · Supplement 42 · priorityAP
1995-02-09Labeling · Supplement 40 · standardAP
1993-09-03Manufacturing (CMC) · Supplement 41 · priorityAP
1993-04-26Efficacy · Supplement 38AP
1992-10-08Labeling · Supplement 39 · standardAP
1992-06-03Labeling · Supplement 37AP
1991-02-15Efficacy · Supplement 35AP
1990-03-09Manufacturing (CMC) · Supplement 34 · priorityAP
1986-08-26Manufacturing (CMC) · Supplement 32 · priorityAP
1986-07-22Manufacturing (CMC) · Supplement 31 · priorityAP
1986-07-22Manufacturing (CMC) · Supplement 30 · priorityAP
1985-07-05Manufacturing (CMC) · Supplement 29 · priorityAP
1985-06-27Manufacturing (CMC) · Supplement 28 · priorityAP
1984-06-12Manufacturing (CMC) · Supplement 27 · priorityAP
1984-05-29Manufacturing (CMC) · Supplement 26 · priorityAP
1983-06-02Manufacturing (CMC) · Supplement 25 · priorityAP
1982-09-17Labeling · Supplement 24AP
1982-09-17Labeling · Supplement 20AP
1982-09-15Labeling · Supplement 22AP
1982-05-13Manufacturing (CMC) · Supplement 23 · priorityAP
1982-04-19Manufacturing (CMC) · Supplement 21 · priorityAP
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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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