ANDA 214296

ZYDUS WORLDWIDE DMCC

FDA Drug Application

Application #214296

Documents

• Letter: 2021-08-16

Application Sponsors

ANDA 214296

ZYDUS WORLDWIDE DMCC

Marketing Status

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

Application Products

001	TABLET;ORAL	140MG	0	IBRUTINIB	IBRUTINIB
002	TABLET;ORAL	280MG	0	IBRUTINIB	IBRUTINIB
003	TABLET;ORAL	420MG	0	IBRUTINIB	IBRUTINIB
004	TABLET;ORAL	560MG	0	IBRUTINIB	IBRUTINIB

FDA Submissions

UNKNOWN;

ORIG

1

TA

2021-07-19

STANDARD

Submissions Property Types

ORIG

1

Null

31

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
        )

)