Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2018-12-07 | STANDARD |
Submissions Property Types
CDER Filings
LUPIN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 210119
[companyName] => LUPIN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/07\/2018","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-12-07
)
)