Application Sponsors
ANDA 214054 | INTAS PHARMS USA | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-03-02 | STANDARD |
Submissions Property Types
CDER Filings
INTAS PHARMS USA
cder:Array
(
[0] => Array
(
[ApplNo] => 214054
[companyName] => INTAS PHARMS USA
[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":"03\/02\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-03-02
)
)