ALVOGEN PINE BROOK FDA Approval ANDA 212763

ANDA 212763

ALVOGEN PINE BROOK

FDA Drug Application

Application #212763

Documents

Letter2021-05-06

Application Sponsors

ANDA 212763ALVOGEN PINE BROOK

Marketing Status

None (Tentative Approval)001

Application Products

001UNKNOWNUNKNOWN0IBRUTINIBIBRUTINIB

FDA Submissions

UNKNOWN; ORIG1TA2021-04-09STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

ALVOGEN PINE BROOK
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212763
            [companyName] => ALVOGEN PINE BROOK
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/09\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-04-09
        )

)

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