Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Prescription | 002 |
Application Products
001 | TABLET;ORAL | 40MG | 0 | FEBUXOSTAT | FEBUXOSTAT |
002 | TABLET;ORAL | 80MG | 0 | FEBUXOSTAT | FEBUXOSTAT |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-02-20 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
SUNSHINE
cder:Array
(
[0] => Array
(
[ApplNo] => 213069
[companyName] => SUNSHINE
[docInserts] => ["",""]
[products] => [{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"FEBUXOSTAT","activeIngredients":"FEBUXOSTAT","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/02\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-06-02
)
)