Application Sponsors
ANDA 215123 | EUGIA PHARMA SPECLTS | |
Marketing Status
None (Tentative Approval) | 001 |
None (Tentative Approval) | 002 |
Application Products
002 | CAPSULE;ORAL | EQ 150MG BASE | 0 | NINTEDANIB | NINTEDANIB |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-05-12 | STANDARD |
Submissions Property Types
CDER Filings
EUGIA PHARMA SPECLTS
cder:Array
(
[0] => Array
(
[ApplNo] => 215123
[companyName] => EUGIA PHARMA SPECLTS
[docInserts] => ["",""]
[products] => [{"drugName":"NINTEDANIB","activeIngredients":"NINTEDANIB","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"NINTEDANIB","activeIngredients":"NINTEDANIB","strength":"EQ 150MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/12\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-05-12
)
)