AKORN INC FDA Approval ANDA 213757

ANDA 213757

AKORN INC

FDA Drug Application

Application #213757

Application Sponsors

ANDA 213757AKORN INC

Marketing Status

Prescription001

Application Products

001SPRAY, METERED;NASAL0.665MG/SPRAY0OLOPATADINE HYDROCHLORIDEOLOPATADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-19STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

CDER Filings

AKORN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213757
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"OLOPATADINE HYDROCHLORIDE","activeIngredients":"OLOPATADINE HYDROCHLORIDE","strength":"0.665MG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/19\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-19
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.