APPLICATION
ANDA209146
TYPE
ANDA
ORIGINAL APPROVAL
2023-10-20
LATEST ACTION
2023-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLUCONAZOLEDiscontinued
FLUCONAZOLE 200MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 100MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 150MG · TABLET · ORAL
FLUCONAZOLEDiscontinued
FLUCONAZOLE 50MG · TABLET · ORAL
Approval history
2023-10-20UNKNOWN · Original · standardAP
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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