Application Sponsors
ANDA 217299 | MSN PHARMS INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2023-01-06 | UNKNOWN |
CDER Filings
MSN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 217299
[companyName] => MSN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/06\/2023","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"UNKNOWN","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2023-01-06
)
)