Application Sponsors
ANDA 213903 | ZHEJIANG YONGNING PHARMACEUTICAL CO LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
001 | TABLET;ORAL | 2.5MG | 0 | APIXABAN | APIXABAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-06-21 | STANDARD |
Submissions Property Types
CDER Filings
ZHEJIANG YONGNING PHARMACEUTICAL CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 213903
[companyName] => ZHEJIANG YONGNING PHARMACEUTICAL CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"APIXABAN","activeIngredients":"APIXABAN","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-06-21
)
)