Application Sponsors
ANDA 214693 | UNICHEM LABS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | TABLET;ORAL | EQ 25MG BASE | 0 | SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE |
002 | TABLET;ORAL | EQ 50MG BASE | 0 | SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE |
003 | TABLET;ORAL | EQ 100MG BASE | 0 | SITAGLIPTIN PHOSPHATE | SITAGLIPTIN PHOSPHATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-07-09 | STANDARD |
Submissions Property Types
CDER Filings
UNICHEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 214693
[companyName] => UNICHEM LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 50MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE","activeIngredients":"SITAGLIPTIN PHOSPHATE","strength":"EQ 100MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/09\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-07-09
)
)