ANDA 207049

AKORN

FDA Drug Application

Application #207049

Application Sponsors

ANDA 207049

AKORN

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	50MG	0	VORICONAZOLE	VORICONAZOLE
002	TABLET;ORAL	200MG	0	VORICONAZOLE	VORICONAZOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2016-09-07

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207049
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/07\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-09-07
        )

)