Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | TABLET;ORAL | 2.5MG | 0 | EMPAGLIFLOZIN | EMPAGLIFLOZIN |
002 | TABLET;ORAL | 10MG | 0 | EMPAGLIFLOZIN | EMPAGLIFLOZIN |
003 | TABLET;ORAL | 25MG | 0 | EMPAGLIFLOZIN | EMPAGLIFLOZIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-12-29 | STANDARD |
Submissions Property Types
CDER Filings
AIZANT
cder:Array
(
[0] => Array
(
[ApplNo] => 212322
[companyName] => AIZANT
[docInserts] => ["",""]
[products] => [{"drugName":"EMPAGLIFLOZIN","activeIngredients":"EMPAGLIFLOZIN","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/29\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212322Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-12-29
)
)