ANDA 202626

MYLAN INSTITUTIONAL

FDA Drug Application

Application #202626

Application Sponsors

ANDA 202626

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

250MG/2.5ML (100MG/ML)

0

ARGATROBAN

ARGATROBAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2014-06-30

Submissions Property Types

ORIG

1

Null

17

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202626
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARGATROBAN","activeIngredients":"ARGATROBAN","strength":"250MG\/2.5ML (100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/30\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-06-30
        )

)