AKORN FDA Approval ANDA 090887

ANDA 090887

AKORN

FDA Drug Application

Application #090887

Application Sponsors

ANDA 090887AKORN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.005%0LATANOPROSTLATANOPROST

FDA Submissions

ORIG1AP2011-07-19
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2014-09-22

Submissions Property Types

ORIG1Null7
SUPPL9Null15

TE Codes

001PrescriptionAT

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90887
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LATANOPROST","activeIngredients":"LATANOPROST","strength":"0.005%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LATANOPROST","submission":"LATANOPROST","actionType":"0.005%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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