APPLICATION
ANDA076351
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2024-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLUCONAZOLEDiscontinued
FLUCONAZOLE 50MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 200MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 100MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 150MG · TABLET · ORAL
Approval history
2024-07-01Labeling · Supplement 17 · standardAP
2022-06-09Labeling · Supplement 16 · standardAP
2022-06-09Labeling · Supplement 15 · standardAP
2021-05-25Labeling · Supplement 9 · standardAP
2021-05-25Labeling · Supplement 12 · standardAP
2021-05-25Labeling · Supplement 13 · standardAP
2021-05-25Labeling · Supplement 11 · standardAP
2012-01-25Labeling · Supplement 8AP
2010-12-28Labeling · Supplement 7AP
2009-11-17Labeling · Supplement 6AP
2004-12-20Labeling · 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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