APPLICATION
ANDA076918
TYPE
ANDA
ORIGINAL APPROVAL
2006-12-18
LATEST ACTION
2015-08-27
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
FLUCONAZOLEDiscontinued
FLUCONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 50MG/5ML · FOR SUSPENSION · ORAL
Approval history
2015-08-27Labeling · Supplement 6 · standardAP
2015-08-27Labeling · Supplement 4 · standardAP
2015-08-27Labeling · Supplement 5 · standardAP
2012-04-18Labeling · Supplement 3AP
2012-01-25Labeling · Supplement 2AP
2008-11-06Labeling · Supplement 1AP
2006-12-18OriginalAP
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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