APPLICATION
ANDA076957
TYPE
ANDA
ORIGINAL APPROVAL
2005-09-28
LATEST ACTION
2024-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FLUCONAZOLEPrescription
FLUCONAZOLE 200MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 50MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 150MG · TABLET · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 100MG · TABLET · ORAL
Approval history
2024-08-26Labeling · Supplement 20 · standardAP
2023-10-24Labeling · Supplement 18 · standardAP
2023-10-24Labeling · Supplement 17 · standardAP
2022-07-12Labeling · Supplement 15 · standardAP
2022-07-12Labeling · Supplement 13 · standardAP
2022-07-12Labeling · Supplement 11 · standardAP
2020-06-22Labeling · Supplement 8 · standardAP
2020-06-22Labeling · Supplement 6 · standardAP
2020-06-22Labeling · Supplement 5 · standardAP
2015-02-02Labeling · Supplement 4 · standardAP
2015-01-09Manufacturing (CMC) · Supplement 3 · unknownAP
2005-09-28OriginalAP
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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