Documents
Application Sponsors
ANDA 214036 | INTAS PHARMS LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | TABLET;ORAL | 15MG/6.14MG | 0 | TRIFLURIDINE; TIPIRACIL | TRIFLURIDINE; TIPIRACIL |
002 | TABLET;ORAL | 20MG/8.19MG | 0 | TRIFLURIDINE; TIPIRACIL | TRIFLURIDINE; TIPIRACIL |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-10-13 | STANDARD |
Submissions Property Types
CDER Filings
INTAS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 214036
[companyName] => INTAS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"TRIFLURIDINE; TIPIRACIL","activeIngredients":"TRIFLURIDINE; TIPIRACIL","strength":"15MG\/6.14MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TRIFLURIDINE; TIPIRACIL","activeIngredients":"TRIFLURIDINE; TIPIRACIL","strength":"20MG\/8.19MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/13\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-10-13
)
)