TORRENT PHARMA INC FDA Approval ANDA 209697

ANDA 209697

TORRENT PHARMA INC

FDA Drug Application

Application #209697

Documents

Letter2019-02-21

Application Sponsors

ANDA 209697TORRENT PHARMA INC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002

Application Products

001TABLET;ORAL7MG0TERIFLUNOMIDETERIFLUNOMIDE
002TABLET;ORAL14MG0TERIFLUNOMIDETERIFLUNOMIDE

FDA Submissions

UNKNOWN; ORIG1TA2019-01-02STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

TORRENT PHARMA INC
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(
    [0] => Array
        (
            [ApplNo] => 209697
            [companyName] => TORRENT PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"7MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TERIFLUNOMIDE","activeIngredients":"TERIFLUNOMIDE","strength":"14MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/02\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209697Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-02
        )

)

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