ANDA 076424

PLIVA

FDA Drug Application

Application #076424

Documents

• Letter: 2004-07-30

Application Sponsors

ANDA 076424

PLIVA

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	TABLET;ORAL	50MG	0	FLUCONAZOLE	FLUCONAZOLE
002	TABLET;ORAL	100MG	0	FLUCONAZOLE	FLUCONAZOLE
003	TABLET;ORAL	150MG	0	FLUCONAZOLE	FLUCONAZOLE
004	TABLET;ORAL	200MG	0	FLUCONAZOLE	FLUCONAZOLE

FDA Submissions

ORIG

1

TA

2003-05-09

Submissions Property Types

ORIG

1

Null

0

CDER Filings

PLIVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76424
            [companyName] => PLIVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLUCONAZOLE","activeIngredients":"FLUCONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLUCONAZOLE","submission":"FLUCONAZOLE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)