Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 200MG | 0 | ENTACAPONE | ENTACAPONE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-10-03 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
SUNSHINE
cder:Array
(
[0] => Array
(
[ApplNo] => 206669
[companyName] => SUNSHINE
[docInserts] => ["",""]
[products] => [{"drugName":"ENTACAPONE","activeIngredients":"ENTACAPONE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/03\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-10-03
)
)