AKORN FDA Approval ANDA 090268

ANDA 090268

AKORN

FDA Drug Application

Application #090268

Application Sponsors

ANDA 090268AKORN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.5%0LEVOFLOXACINLEVOFLOXACIN

FDA Submissions

ORIG1AP2010-12-20
LABELING; LabelingSUPPL3AP2017-02-07STANDARD

Submissions Property Types

ORIG1Null42
SUPPL3Null7

TE Codes

001PrescriptionAT

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90268
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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