APPLICATION
ANDA078423
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-07
LATEST ACTION
2025-01-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUCONAZOLEPrescription
FLUCONAZOLE 200MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 100MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 150MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 50MG · TABLET · ORAL
Approval history
2025-01-29Labeling · Supplement 27 · standardAP
2025-01-29Labeling · Supplement 31 · standardAP
2021-04-27Labeling · Supplement 13 · standardAP
2021-04-27Labeling · Supplement 9 · standardAP
2021-04-27Labeling · Supplement 12 · standardAP
2017-03-10Manufacturing (CMC) · Supplement 7 · unknownAP
2015-03-14Labeling · Supplement 2 · standardAP
2015-03-14Labeling · Supplement 1 · standardAP
2011-03-07OriginalAP
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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