ANDA 204731

AKORN INC

FDA Drug Application

Application #204731

Application Sponsors

ANDA 204731

AKORN INC

Marketing Status

• None (Tentative Approval): 001

Application Products

001

INJECTABLE;INJECTION

0.25MG(BASE)/5ML

0

PALONOSETRON HYDROCHLORIDE

PALONOSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

TA

2015-11-09

Submissions Property Types

ORIG

1

Null

17

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204731
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"0.25MG(BASE)\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/09\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-09
        )

)