ANDA 090874

MYLAN INSTITUTIONAL

FDA Drug Application

Application #090874

Documents

• Letter: 2010-07-27

Application Sponsors

ANDA 090874

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1%

0

ISOSULFAN BLUE

ISOSULFAN BLUE

FDA Submissions

ORIG

1

AP

2010-07-20

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90874
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSULFAN BLUE","activeIngredients":"ISOSULFAN BLUE","strength":"1%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSULFAN BLUE","submission":"ISOSULFAN BLUE","actionType":"1%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)