ANDA 090574

MYLAN INSTITUTIONAL

FDA Drug Application

Application #090574

Documents

• Letter: 2009-12-24

Application Sponsors

ANDA 090574

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.25MG/VIAL

0

COSYNTROPIN

COSYNTROPIN

FDA Submissions

ORIG

1

AP

2009-12-17

Submissions Property Types

ORIG

1

Null

3

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90574
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"COSYNTROPIN","activeIngredients":"COSYNTROPIN","strength":"0.25MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"COSYNTROPIN","submission":"COSYNTROPIN","actionType":"0.25MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)