Documents
Application Sponsors
ANDA 209633 | BRECKENRIDGE PHARMS | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | TABLET;ORAL | 5MG | 0 | TOFACITINIB | TOFACITINIB |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2019-06-07 | STANDARD |
Submissions Property Types
CDER Filings
BRECKENRIDGE PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 209633
[companyName] => BRECKENRIDGE PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TOFACITINIB","activeIngredients":"TOFACITINIB","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/10\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209633Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-06-10
)
)