ANDA 090163

AKORN INC

FDA Drug Application

Application #090163

Application Sponsors

ANDA 090163

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/25ML (2MG/ML)

0

EPIRUBICIN HYDROCHLORIDE

EPIRUBICIN HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2009-06-24

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90163
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPIRUBICIN HYDROCHLORIDE","activeIngredients":"EPIRUBICIN HYDROCHLORIDE","strength":"50MG\/25ML (2MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"EPIRUBICIN HYDROCHLORIDE","submission":"EPIRUBICIN HYDROCHLORIDE","actionType":"50MG\/25ML (2MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)