ANDA 076488

MYLAN INSTITUTIONAL

FDA Drug Application

Application #076488

Application Sponsors

ANDA 076488

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INTRAVENOUS

100MG/ML

0

MESNA

MESNA

FDA Submissions

	ORIG	1	AP	2012-03-08
LABELING; Labeling	SUPPL	3	AP	2016-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76488
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MESNA","activeIngredients":"MESNA","strength":"100MG\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MESNA","submission":"MESNA","actionType":"100MG\/ML","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)