Application Sponsors
ANDA 202365 | WATSON LABS INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | TABLET;ORAL | 50MG;500MG | 0 | SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE | SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
002 | TABLET;ORAL | 50MG;1000MG | 0 | SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE | SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2015-10-30 | |
Submissions Property Types
CDER Filings
WATSON LABS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202365
[companyName] => WATSON LABS INC
[docInserts] => ["",""]
[products] => [{"drugName":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","strength":"50MG;500MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","activeIngredients":"SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE","strength":"50MG;1000MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/30\/2015","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2015-10-30
)
)