Application Sponsors
ANDA 216915 | LOTUS PHARM CO LTD | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2023-01-12 | STANDARD |
Submissions Property Types
CDER Filings
LOTUS PHARM CO LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 216915
[companyName] => LOTUS PHARM CO LTD
[docInserts] => ["",""]
[products] => [{"drugName":"NINTEDANIB","activeIngredients":"NINTEDANIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NINTEDANIB","activeIngredients":"NINTEDANIB","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/12\/2023","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2023-01-12
)
)