APPLICATION
ANDA077731
TYPE
ANDA
ORIGINAL APPROVAL
2008-10-07
LATEST ACTION
2024-06-17
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
2024-06-17Labeling · Supplement 33 · standardAP
2023-10-24Labeling · Supplement 30 · standardAP
2023-03-30Labeling · Supplement 28 · standardAP
2022-07-06Labeling · Supplement 25 · standardAP
2022-07-06Labeling · Supplement 26 · standardAP
2021-10-06Labeling · Supplement 23 · standardAP
2019-07-08Labeling · Supplement 19 · standardAP
2019-07-08Labeling · Supplement 15 · standardAP
2019-07-08Labeling · Supplement 16 · standardAP
2019-07-08Labeling · Supplement 14 · standardAP
2015-01-29Labeling · Supplement 9 · standardAP
2015-01-29Labeling · Supplement 11 · standardAP
2015-01-29Labeling · Supplement 8 · standardAP
2012-01-23Labeling · Supplement 6AP
2011-12-01Labeling · Supplement 5AP
2011-10-13Labeling · Supplement 3AP
2008-10-07OriginalAP
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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