Documents
Application Sponsors
NDA 211566 | ZYDUS WORLDWIDE DMCC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | TABLET; ORAL | 25MG | 0 | SITAGLIPTIN | SITAGLIPTIN |
FDA Submissions
TYPE 2; Type 2 - New Active Ingredient | ORIG | 1 | TA | 2021-09-02 | STANDARD |
Submissions Property Types
CDER Filings
ZYDUS WORLDWIDE DMCC
cder:Array
(
[0] => Array
(
[ApplNo] => 211566
[companyName] => ZYDUS WORLDWIDE DMCC
[docInserts] => ["",""]
[products] => [{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"25MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"50MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN","activeIngredients":"SITAGLIPTIN","strength":"100MG","dosageForm":"TABLET; ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/02\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"Type 2 - New Active Ingredient","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211566Orig1s000TAltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-09-02
)
)