ZYDUS WORLDWIDE DMCC FDA Approval NDA 211566

NDA 211566

ZYDUS WORLDWIDE DMCC

FDA Drug Application

Application #211566

Documents

Letter2021-09-08

Application Sponsors

NDA 211566ZYDUS WORLDWIDE DMCC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

001TABLET; ORAL25MG0SITAGLIPTINSITAGLIPTIN

FDA Submissions

TYPE 2; Type 2 - New Active IngredientORIG1TA2021-09-02STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS WORLDWIDE DMCC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211566
            [companyName] => ZYDUS WORLDWIDE DMCC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"100MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/02\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211566Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-02
        )

)

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