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FDA ANDA · ANDA074926
MICONAZOLE 3 COMBINATION PACK
miconazole nitrate
Sponsor: COSETTE PHARMS NC
APPLICATION
ANDA074926
TYPE
ANDA
ORIGINAL APPROVAL
1999-04-16
LATEST ACTION
2018-06-19
ROUTE
TOPICAL, VAGINAL
DOSAGE FORM
CREAM, SUPPOSITORY
MARKETING STATUS
Over-the-counter
Products
M-ZOLE 3 COMBINATION PACKOver-the-counter
MICONAZOLE NITRATE 2%,200MG · CREAM, SUPPOSITORY · TOPICAL, VAGINAL
Approval history
2018-06-19Labeling · Supplement 18 · standardAP
2005-04-08Labeling · Supplement 8AP
2003-08-14Labeling · Supplement 6AP
2002-11-21Labeling · Supplement 4AP
2002-03-15Manufacturing (CMC) · Supplement 3AP
2001-12-04Manufacturing (CMC) · Supplement 2AP
2000-12-29Manufacturing (CMC) · Supplement 1AP
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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