AKORN FDA Approval ANDA 212080

ANDA 212080

AKORN

FDA Drug Application

Application #212080

Application Sponsors

ANDA 212080AKORN

Marketing Status

Prescription001

Application Products

001GEL;OPHTHALMIC0.5%0LOTEPREDNOL ETABONATELOTEPREDNOL ETABONATE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-10STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212080
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LOTEPREDNOL ETABONATE","activeIngredients":"LOTEPREDNOL ETABONATE","strength":"0.5%","dosageForm":"GEL;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)

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