APPLICATION
ANDA079150
TYPE
ANDA
ORIGINAL APPROVAL
2009-09-18
LATEST ACTION
2024-07-16
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription
Products
FLUCONAZOLEPrescription
FLUCONAZOLE 50MG/5ML · FOR SUSPENSION · ORAL
FLUCONAZOLEPrescription
FLUCONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL
Approval history
2024-07-16Labeling · Supplement 26 · standardAP
2023-12-27Labeling · Supplement 23 · standardAP
2023-03-17Labeling · Supplement 21 · standardAP
2023-01-19Labeling · Supplement 13 · standardAP
2023-01-19Labeling · Supplement 11 · standardAP
2023-01-19Labeling · Supplement 18 · standardAP
2023-01-19Labeling · Supplement 16 · standardAP
2023-01-19Labeling · Supplement 12 · standardAP
2023-01-19Labeling · Supplement 10 · standardAP
2023-01-19Labeling · Supplement 19 · standardAP
2015-02-27Labeling · Supplement 7 · standardAP
2015-02-27Labeling · Supplement 8 · standardAP
2015-02-27Labeling · Supplement 6 · standardAP
2012-01-23Labeling · Supplement 3AP
2012-01-23Labeling · Supplement 4AP
2010-12-27Labeling · Supplement 2AP
2009-09-18OriginalAP
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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