ANDA 078151

AKORN

FDA Drug Application

Application #078151

Documents

• Other Important Information from FDA: 2011-02-17

Application Sponsors

ANDA 078151

AKORN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

1MG/ML

0

TERBUTALINE SULFATE

TERBUTALINE SULFATE

FDA Submissions

ORIG

1

AP

2008-01-07

Submissions Property Types

SUPPL

1

Null

7

TE Codes

001

Prescription

AP

CDER Filings

AKORN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78151
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERBUTALINE SULFATE","activeIngredients":"TERBUTALINE SULFATE","strength":"1MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TERBUTALINE SULFATE","submission":"TERBUTALINE SULFATE","actionType":"1MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)