Documents
Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | CAPSULE;ORAL | 70MG | 0 | IBRUTINIB | IBRUTINIB |
002 | CAPSULE;ORAL | 140MG | 0 | IBRUTINIB | IBRUTINIB |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-03-31 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
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
)
)