ZYDUS WORLDWIDE DMCC FDA Approval ANDA 214296

ANDA 214296

ZYDUS WORLDWIDE DMCC

FDA Drug Application

Application #214296

Documents

Letter2021-08-16

Application Sponsors

ANDA 214296ZYDUS WORLDWIDE DMCC

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003
None (Tentative Approval)004

Application Products

001TABLET;ORAL140MG0IBRUTINIBIBRUTINIB
002TABLET;ORAL280MG0IBRUTINIBIBRUTINIB
003TABLET;ORAL420MG0IBRUTINIBIBRUTINIB
004TABLET;ORAL560MG0IBRUTINIBIBRUTINIB

FDA Submissions

UNKNOWN; ORIG1TA2021-07-19STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ZYDUS WORLDWIDE DMCC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214296
            [companyName] => ZYDUS WORLDWIDE DMCC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"140MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"280MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"420MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"560MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/19\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-07-19
        )

)

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