Application Sponsors
ANDA 209864 | HAINAN POLY PHARM | |
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 | 2019-01-25 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
CDER Filings
HAINAN POLY PHARM
cder:Array
(
[0] => Array
(
[ApplNo] => 209864
[companyName] => HAINAN POLY PHARM
[docInserts] => ["",""]
[products] => [{"drugName":"EPTIFIBATIDE","activeIngredients":"EPTIFIBATIDE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EPTIFIBATIDE","activeIngredients":"EPTIFIBATIDE","strength":"75MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/25\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-01-25
)
)