Documents
Application Sponsors
ANDA 077973 | SYNTHON PHARMS | |
Marketing Status
Application Products
001 | TABLET;ORAL | 50MG | 0 | BICALUTAMIDE | BICALUTAMIDE |
FDA Submissions
| ORIG | 1 | AP | 2009-07-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2011-01-07 | |
LABELING; Labeling | SUPPL | 3 | AP | 2011-04-26 | |
Submissions Property Types
CDER Filings
SYNTHON PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 77973
[companyName] => SYNTHON PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"BICALUTAMIDE","activeIngredients":"BICALUTAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"07\/06\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/077973s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"BICALUTAMIDE","submission":"BICALUTAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2009-07-06
)
)