AKORN FDA Approval ANDA 091268

ANDA 091268

AKORN

FDA Drug Application

Application #091268

Application Sponsors

ANDA 091268AKORN

Marketing Status

Prescription002

Application Products

002INJECTABLE;INTRAVENOUS600MG/60ML (10MG/ML)0CARBOPLATINCARBOPLATIN

FDA Submissions

ORIG1AP2010-07-28

Submissions Property Types

ORIG1Null7

TE Codes

002PrescriptionAP

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91268
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARBOPLATIN","activeIngredients":"CARBOPLATIN","strength":"600MG\/60ML (10MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CARBOPLATIN","submission":"CARBOPLATIN","actionType":"600MG\/60ML (10MG\/ML)","submissionClassification":"INJECTABLE;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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