Application Sponsors
ANDA 213762 | AXAR PHARMA INC | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | UNKNOWN | UNKNOWN | 0 | ARFORMOTEROL TARTRATE | ARFORMOTEROL TARTRATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-02-03 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AXAR PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 213762
[companyName] => AXAR PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"ARFORMOTEROL TARTRATE","activeIngredients":"ARFORMOTEROL TARTRATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/03\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-02-03
)
)