PRINSTON PHARMA INC FDA Approval ANDA 209923

ANDA 209923

PRINSTON PHARMA INC

FDA Drug Application

Application #209923

Documents

Letter2018-10-17

Application Sponsors

ANDA 209923PRINSTON PHARMA INC

Marketing Status

None (Tentative Approval)001

Application Products

001TABLET;ORAL5MG0TOFACITINIBTOFACITINIB

FDA Submissions

UNKNOWN; ORIG1TA2018-09-25STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

PRINSTON PHARMA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209923
            [companyName] => PRINSTON PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/25\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209923Orig1s000TALtr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-09-25
        )

)

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