Application Sponsors
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | INJECTABLE;INJECTION | 2MG/ML | 0 | EPTIFIBATIDE | EPTIFIBATIDE |
002 | INJECTABLE;INJECTION | 75MG/100ML | 0 | EPTIFIBATIDE | EPTIFIBATIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-09-07 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
SHUANGCHENG
cder:Array
(
[0] => Array
(
[ApplNo] => 213081
[companyName] => SHUANGCHENG
[docInserts] => ["",""]
[products] => [{"drugName":"EPTIFIBATIDE","activeIngredients":"EPTIFIBATIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-09-07
)
)