ANDA 090643

MYLAN INSTITUTIONAL

FDA Drug Application

Application #090643

Documents

• Letter: 2010-01-15

Application Sponsors

ANDA 090643

MYLAN INSTITUTIONAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

0.1MG/ML

0

IBUTILIDE FUMARATE

IBUTILIDE FUMARATE

FDA Submissions

ORIG

1

AP

2010-01-11

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90643
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUTILIDE FUMARATE","activeIngredients":"IBUTILIDE FUMARATE","strength":"0.1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUTILIDE FUMARATE","submission":"IBUTILIDE FUMARATE","actionType":"0.1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)