ALVOGEN INC FDA Approval ANDA 214498

ANDA 214498

ALVOGEN INC

FDA Drug Application

Application #214498

Application Sponsors

ANDA 214498ALVOGEN INC

Marketing Status

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

Application Products

001CAPSULE;ORAL70MG0IBRUTINIBIBRUTINIB
002CAPSULE;ORAL140MG0IBRUTINIBIBRUTINIB

FDA Submissions

UNKNOWN; ORIG1TA2021-06-03STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ALVOGEN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214498
            [companyName] => ALVOGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"70MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/03\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-03
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.