ANDA 202361

MYLAN PHARMS INC

FDA Drug Application

Application #202361

Application Sponsors

ANDA 202361

MYLAN PHARMS INC

Marketing Status

• Discontinued: 001

Application Products

001

FOR SUSPENSION;ORAL

200MG/5ML

0

VORICONAZOLE

VORICONAZOLE

FDA Submissions

	ORIG	1	AP	2013-05-28
LABELING; Labeling	SUPPL	2	AP	2015-05-08	STANDARD
LABELING; Labeling	SUPPL	3	AP	2015-05-08	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	3	Null	7

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202361
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VORICONAZOLE","activeIngredients":"VORICONAZOLE","strength":"200MG\/5ML","dosageForm":"FOR SUSPENSION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/28\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"05\/08\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/08\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2015-05-08
        )

)