MYLAN FDA Approval ANDA 209564

ANDA 209564

MYLAN

FDA Drug Application

Application #209564

Application Sponsors

ANDA 209564MYLAN

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL145MCG0LINACLOTIDELINACLOTIDE
002CAPSULE;ORAL290MCG0LINACLOTIDELINACLOTIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-02-09STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

MYLAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209564
            [companyName] => MYLAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LINACLOTIDE","activeIngredients":"LINACLOTIDE","strength":"145MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LINACLOTIDE","activeIngredients":"LINACLOTIDE","strength":"290MCG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/09\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-09
        )

)

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