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FDA NDA · NDA021308

MICONAZOLE 1 WALGREENS

miconazole nitrate

Sponsor: MEDTECH PRODUCTS

APPLICATION
NDA021308
TYPE
NDA
ORIGINAL APPROVAL
2001-06-29
LATEST ACTION
2020-07-22
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM, INSERT
MARKETING STATUS
Over-the-counter

Products

MONISTAT 1 COMBINATION PACK · ReferenceOver-the-counter
MICONAZOLE NITRATE 2%,1.2GM · CREAM, INSERT · TOPICAL, VAGINAL

Approval history

2020-07-22Manufacturing (CMC) · Supplement 31 — Letter ↗AP
2020-01-28Labeling · Supplement 30 · standard — Label ↗AP
2014-02-11Manufacturing (CMC) · Supplement 21 · standardAP
2013-07-10Manufacturing (CMC) · Supplement 19 · standardAP
2013-03-13Manufacturing (CMC) · Supplement 20 · standardAP
2013-02-06Manufacturing (CMC) · Supplement 18 · standardAP
2005-04-04Labeling · Supplement 10 · standard — Label ↗AP
2004-10-01Efficacy · Supplement 9 · standard — Label ↗AP
2003-12-03Manufacturing (CMC) · Supplement 8 · standard — Letter ↗AP
2002-11-20Labeling · Supplement 5 · standard — Letter ↗AP
2002-10-28Manufacturing (CMC) · Supplement 3 · standardAP
2002-09-06Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2002-05-06Manufacturing (CMC) · Supplement 1 · standardAP
2002-04-10Manufacturing (CMC) · Supplement 2 · standardAP
2001-06-29Type 3 - New Dosage Form · 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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