Application Sponsors
ANDA 209945 | ECI PHARMS LLC | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 250MG | 0 | TRIENTINE HYDROCHLORIDE | TRIENTINE HYDROCHLORIDE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2021-08-13 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ECI PHARMS LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 209945
[companyName] => ECI PHARMS LLC
[docInserts] => ["",""]
[products] => [{"drugName":"TRIENTINE HYDROCHLORIDE","activeIngredients":"TRIENTINE HYDROCHLORIDE","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-08-13
)
)