APPLICATION
ANDA076507
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2015-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLUCONAZOLEDiscontinued
FLUCONAZOLE 150MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 50MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 200MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 100MG · TABLET · ORAL
Approval history
2015-03-19Labeling · Supplement 6 · standardAP
2015-03-19Labeling · Supplement 7 · standardAP
2015-03-19Labeling · Supplement 5 · standardAP
2012-04-18Labeling · Supplement 4AP
2011-12-16Labeling · Supplement 3AP
2008-11-06Labeling · Supplement 2AP
2008-01-09Manufacturing (CMC) · 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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