APPLICATION
ANDA076658
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2024-06-25
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
2024-06-25Labeling · Supplement 25 · standardAP
2023-10-24Labeling · Supplement 24 · standardAP
2023-06-07Labeling · Supplement 23 · standardAP
2022-07-06Labeling · Supplement 19 · standardAP
2022-07-06Labeling · Supplement 21 · standardAP
2022-07-06Labeling · Supplement 20 · standardAP
2019-07-16Labeling · Supplement 17 · standardAP
2019-07-16Labeling · Supplement 15 · standardAP
2019-07-16Labeling · Supplement 16 · standardAP
2019-07-16Labeling · Supplement 14 · standardAP
2015-03-14Labeling · Supplement 9 · standardAP
2015-03-14Labeling · Supplement 5 · standardAP
2015-03-14Labeling · Supplement 4 · standardAP
2005-11-09Labeling · 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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