Documents
Application Sponsors
ANDA 213064 | ZYDUS PHARMS USA INC | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
None (Tentative Approval) | 003 |
Application Products
001 | TABLET;ORAL | 15MG | 0 | EDOXABAN | EDOXABAN |
002 | TABLET;ORAL | 30MG | 0 | EDOXABAN | EDOXABAN |
003 | TABLET;ORAL | 60MG | 0 | EDOXABAN | EDOXABAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-11-16 | STANDARD |
Submissions Property Types
CDER Filings
ZYDUS PHARMS USA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 213064
[companyName] => ZYDUS PHARMS USA INC
[docInserts] => ["",""]
[products] => [{"drugName":"EDOXABAN","activeIngredients":"EDOXABAN","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EDOXABAN","activeIngredients":"EDOXABAN","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"EDOXABAN","activeIngredients":"EDOXABAN","strength":"60MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/16\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-11-16
)
)