ZYDUS FDA Approval ANDA 211344

ANDA 211344

ZYDUS

FDA Drug Application

Application #211344

Documents

Letter2021-04-13

Application Sponsors

ANDA 211344ZYDUS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL70MG0IBRUTINIBIBRUTINIB
002CAPSULE;ORAL140MG0IBRUTINIBIBRUTINIB

FDA Submissions

UNKNOWN; ORIG1AP2021-03-31STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

ZYDUS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211344
            [companyName] => ZYDUS
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"70MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IBRUTINIB","activeIngredients":"IBRUTINIB","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/31\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-31
        )

)

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