PHARMACYCLICS INC FDA Approval NDA 217003

NDA 217003

PHARMACYCLICS INC

FDA Drug Application

Application #217003

Documents

Label2022-08-25

Application Sponsors

NDA 217003PHARMACYCLICS INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006
Prescription007

Application Products

001SUSPENSION;ORAL70MG/ML0IMBRUVICAIBRUTINIB
002CAPSULE;ORAL70MG0IMBRUVICAIBRUTINIB
003CAPSULE;ORAL140MG0IMBRUVICAIBRUTINIB
004TABLET;ORAL140MG0IMBRUVICAIBRUTINIB
005TABLET;ORAL230MG0IMBRUVICAIBRUTINIB
006TABLET;ORAL420MG0IMBRUVICAIBRUTINIB
007TABLET;ORAL560MG0IMBRUVICAIBRUTINIB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2022-08-24PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

PHARMACYCLICS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 217003
            [companyName] => PHARMACYCLICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"70MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"70MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"140MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"140MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"230MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"420MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"IMBRUVICA","activeIngredients":"IBRUTINIB","strength":"560MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/24\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/217003s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/24\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/217003s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-08-24
        )

)

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