Documents
Application Sponsors
ANDA 212264 | PRINSTON PHARMA INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
002 | TABLET;ORAL | 25MG;5MG | 0 | EMPAGLIFLOZIN AND LINAGLIPTIN | EMPAGLIFLOZIN; LINAGLIPTIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-01-20 | STANDARD |
Submissions Property Types
CDER Filings
PRINSTON PHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212264
[companyName] => PRINSTON PHARMA INC
[docInserts] => ["",""]
[products] => [{"drugName":"EMPAGLIFLOZIN AND LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN","strength":"10MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EMPAGLIFLOZIN AND LINAGLIPTIN","activeIngredients":"EMPAGLIFLOZIN; LINAGLIPTIN","strength":"25MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/20\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/212264Orig1s000TA_ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-01-20
)
)