Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Application Products
001 | TABLET;ORAL | 0.5MG | 0 | ENTECAVIR | ENTECAVIR |
002 | TABLET;ORAL | 1MG | 0 | ENTECAVIR | ENTECAVIR |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-11-23 | STANDARD |
Submissions Property Types
CDER Filings
PAR PHARM INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206294
[companyName] => PAR PHARM INC
[docInserts] => ["",""]
[products] => [{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ENTECAVIR","activeIngredients":"ENTECAVIR","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/23\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2016-11-23
)
)