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FDA ANDA · ANDA076213

FLUCONAZOLE

Sponsor: ROXANE

APPLICATION
ANDA076213
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2005-12-06
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

2005-12-06Labeling · Supplement 2AP
2004-07-29OriginalLetterAP
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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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