Application Sponsors
ANDA 078634 | WATSON LABS TEVA | |
Marketing Status
Application Products
001 | TABLET;ORAL | 50MG | 0 | BICALUTAMIDE | BICALUTAMIDE |
FDA Submissions
| ORIG | 1 | AP | 2009-08-28 | |
LABELING; Labeling | SUPPL | 4 | AP | 2016-05-10 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2016-05-10 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2019-02-07 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 4 | Null | 15 |
SUPPL | 5 | Null | 15 |
SUPPL | 6 | Null | 7 |
TE Codes
CDER Filings
WATSON LABS TEVA
cder:Array
(
[0] => Array
(
[ApplNo] => 78634
[companyName] => WATSON LABS TEVA
[docInserts] => ["",""]
[products] => [{"drugName":"BICALUTAMIDE","activeIngredients":"BICALUTAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BICALUTAMIDE","submission":"BICALUTAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)