LUPIN ATLANTIS FDA Approval ANDA 209954

ANDA 209954

LUPIN ATLANTIS

FDA Drug Application

Application #209954

Application Sponsors

ANDA 209954LUPIN ATLANTIS

Marketing Status

Prescription001

Application Products

001AEROSOL, METERED;INHALATIONEQ 0.09MG BASE/INH0ALBUTEROL SULFATEALBUTEROL SULFATE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-24STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB2

CDER Filings

LUPIN ATLANTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209954
            [companyName] => LUPIN ATLANTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 0.09MG BASE\/INH","dosageForm":"AEROSOL, METERED;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/24\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-24
        )

)

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