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FDA NDA · NDA021261

MONISTAT 3 COMBINATION PACK

miconazole nitrate

Sponsor: MEDTECH PRODUCTS

APPLICATION
NDA021261
TYPE
NDA
ORIGINAL APPROVAL
2001-02-02
LATEST ACTION
2020-07-22
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter

Products

MONISTAT 3 COMBINATION PACK · ReferenceOver-the-counter
MICONAZOLE NITRATE 2%,4% · CREAM · TOPICAL, VAGINAL
MONISTAT 3 COMBINATION PACK (PREFILLED) · ReferenceOver-the-counter
MICONAZOLE NITRATE 2%,4% · CREAM · TOPICAL, VAGINAL

Approval history

2020-07-22Manufacturing (CMC) · Supplement 25 — Letter ↗AP
2020-01-28Labeling · Supplement 24 · standard — Label ↗AP
2014-03-10Manufacturing (CMC) · Supplement 18 · standardAP
2014-02-27Manufacturing (CMC) · Supplement 17 · standardAP
2014-02-11Manufacturing (CMC) · Supplement 16 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 14 · standardAP
2013-01-29Manufacturing (CMC) · Supplement 13 · standardAP
2009-12-21Manufacturing (CMC) · Supplement 9 — Label ↗AP
2008-10-28Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2003-06-17Labeling · Supplement 4 · standard — Letter ↗AP
2002-10-28Manufacturing (CMC) · Supplement 3 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 2 · standardAP
2001-11-28Manufacturing (CMC) · Supplement 1 · standardAP
2001-02-02Type 4 - New Combination · Original · standard — Label ↗AP
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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