ANDA 040647

MYLAN INSTITUTIONAL

FDA Drug Application

Application #040647

Documents

• Review: 2012-09-12

Application Sponsors

ANDA 040647

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

200MG/ML

0

TESTOSTERONE ENANTHATE

TESTOSTERONE ENANTHATE

FDA Submissions

	ORIG	1	AP	2009-10-05
LABELING; Labeling	SUPPL	2	AP	2015-09-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-09-23	STANDARD

Submissions Property Types

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

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40647
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"TESTOSTERONE ENANTHATE","activeIngredients":"TESTOSTERONE ENANTHATE","strength":"200MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TESTOSTERONE ENANTHATE","submission":"TESTOSTERONE ENANTHATE","actionType":"200MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)