ANDA 065371

MYLAN INSTITUTIONAL

FDA Drug Application

Application #065371

Application Sponsors

ANDA 065371

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	50MG/25ML (2MG/ML)	0	EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE
002	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	0	EPIRUBICIN HYDROCHLORIDE	EPIRUBICIN HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2007-11-28

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 65371
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPIRUBICIN HYDROCHLORIDE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"EPIRUBICIN HYDROCHLORIDE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"200MG\/100ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EPIRUBICIN HYDROCHLORIDE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"50MG\/25ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"EPIRUBICIN HYDROCHLORIDE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"200MG\/100ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)