AUCTA FDA Approval ANDA 216486

ANDA 216486

AUCTA

FDA Drug Application

Application #216486

Application Sponsors

ANDA 216486AUCTA

Marketing Status

Prescription001

Application Products

001SOLUTION;INHALATION0.02MG/2ML0FORMOTEROL FUMARATEFORMOTEROL FUMARATE

FDA Submissions

UNKNOWN; ORIG1AP2022-11-25STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAN

CDER Filings

AUCTA
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216486
            [companyName] => AUCTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"FORMOTEROL FUMARATE","activeIngredients":"FORMOTEROL FUMARATE","strength":"0.02MG\/2ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/25\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-11-25
        )

)

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