SUN PHARM FDA Approval ANDA 215385

ANDA 215385

SUN PHARM

FDA Drug Application

Application #215385

Application Sponsors

ANDA 215385SUN PHARM

Marketing Status

Prescription001

Application Products

001SOLUTION;INHALATIONEQ 0.015MG BASE/2ML0ARFORMOTEROL TARTRATEARFORMOTEROL TARTRATE

FDA Submissions

UNKNOWN; ORIG1AP2022-05-26STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAN

CDER Filings

SUN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215385
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARFORMOTEROL TARTRATE","activeIngredients":"ARFORMOTEROL TARTRATE","strength":"EQ 0.015MG BASE\/2ML","dosageForm":"SOLUTION;INHALATION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/26\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-05-26
        )

)

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