Documents
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
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
)
)