ANDA 079033

MYLAN INSTITUTIONAL

FDA Drug Application

Application #079033

Application Sponsors

ANDA 079033

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1.5GM/1.5ML (1GM/ML)

0

FOMEPIZOLE

FOMEPIZOLE

FDA Submissions

ORIG

1

AP

2009-04-07

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79033
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOMEPIZOLE","activeIngredients":"FOMEPIZOLE","strength":"1.5GM\/1.5ML (1GM\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FOMEPIZOLE","submission":"FOMEPIZOLE","actionType":"1.5GM\/1.5ML (1GM\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)