MSN PHARMACEUTICALS INC FDA Approval ANDA 213703

ANDA 213703

MSN PHARMACEUTICALS INC

FDA Drug Application

Application #213703

Documents

Letter2021-12-21

Application Sponsors

ANDA 213703MSN PHARMACEUTICALS INC

Marketing Status

None (Tentative Approval)001

FDA Submissions

UNKNOWN; ORIG1TA2021-11-22STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

MSN PHARMACEUTICALS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213703
            [companyName] => MSN PHARMACEUTICALS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CANGRELOR","activeIngredients":"CANGRELOR","strength":"50MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/22\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213703Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-22
        )

)

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