APPLICATION
ANDA208963
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-16
LATEST ACTION
2024-08-15
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
2024-08-15Labeling · Supplement 17 · standardAP
2024-01-23Labeling · Supplement 15 · standardAP
2024-01-23Labeling · Supplement 13 · standardAP
2022-06-09Labeling · Supplement 11 · standardAP
2022-06-09Labeling · Supplement 10 · standardAP
2021-10-06Labeling · Supplement 9 · standardAP
2019-07-16Labeling · Supplement 2 · standardAP
2019-07-16Labeling · Supplement 5 · standardAP
2019-07-16Labeling · Supplement 3 · standardAP
2019-07-16Labeling · Supplement 1 · standardAP
2017-02-16UNKNOWN · Original · standardAP
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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