APPLICATION
ANDA076665
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2020-06-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUCONAZOLEPrescription
FLUCONAZOLE 150MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 50MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 200MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 100MG · TABLET · ORAL
Approval history
2020-06-22Labeling · Supplement 10 · standardAP
2020-06-22Labeling · Supplement 9 · standardAP
2020-06-22Labeling · Supplement 11 · standardAP
2015-03-14Labeling · Supplement 7 · standardAP
2015-03-14Labeling · Supplement 8 · standardAP
2015-03-14Labeling · Supplement 6 · standardAP
2005-05-27Labeling · 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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