ANDA 040652

MYLAN INSTITUTIONAL

FDA Drug Application

Application #040652

Application Sponsors

ANDA 040652

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

TESTOSTERONE CYPIONATE

TESTOSTERONE CYPIONATE

FDA Submissions

	ORIG	1	AP	2006-12-11
LABELING; Labeling	SUPPL	5	AP	2014-06-19	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-05-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-07-15	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-10-25	STANDARD

Submissions Property Types

SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	15
SUPPL	8	Null	7

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40652
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE CYPIONATE","activeIngredients":"TESTOSTERONE CYPIONATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TESTOSTERONE CYPIONATE","submission":"TESTOSTERONE CYPIONATE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)