NDA 217003

PHARMACYCLICS INC

FDA Drug Application

Application #217003

Documents

• Label: 2022-08-25

Application Sponsors

NDA 217003

PHARMACYCLICS INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006
• Prescription: 007

Application Products

001	SUSPENSION;ORAL	70MG/ML	0	IMBRUVICA	IBRUTINIB
002	CAPSULE;ORAL	70MG	0	IMBRUVICA	IBRUTINIB
003	CAPSULE;ORAL	140MG	0	IMBRUVICA	IBRUTINIB
004	TABLET;ORAL	140MG	0	IMBRUVICA	IBRUTINIB
005	TABLET;ORAL	230MG	0	IMBRUVICA	IBRUTINIB
006	TABLET;ORAL	420MG	0	IMBRUVICA	IBRUTINIB
007	TABLET;ORAL	560MG	0	IMBRUVICA	IBRUTINIB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2022-08-24

PRIORITY

Submissions Property Types

ORIG

1

Null

6

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
        )

)