Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2020-03-17 | STANDARD |
Submissions Property Types
CDER Filings
SANDOZ INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210993
[companyName] => SANDOZ INC
[docInserts] => ["",""]
[products] => [{"drugName":"VORTIOXETINE","activeIngredients":"VORTIOXETINE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"03\/17\/2020","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/210993Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-03-17
)
)