APPLICATION
ANDA076077
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2025-08-15
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
2025-08-15Labeling · Supplement 22 · standardAP
2023-10-24Labeling · Supplement 20 · standardAP
2023-10-24Labeling · Supplement 19 · standardAP
2023-10-24Labeling · Supplement 21 · standardAP
2021-10-06Labeling · Supplement 18 · standardAP
2019-07-16Labeling · Supplement 15 · standardAP
2019-07-16Labeling · Supplement 13 · standardAP
2019-07-16Labeling · Supplement 16 · standardAP
2019-07-16Labeling · Supplement 14 · standardAP
2015-03-18Labeling · Supplement 10 · standardAP
2015-03-18Labeling · Supplement 11 · standardAP
2012-01-23Labeling · Supplement 6AP
2012-01-23Labeling · Supplement 5AP
2010-12-27Labeling · Supplement 4AP
2008-06-27Labeling · Supplement 2AP
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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