Application Sponsors
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | 250MG/50ML (5MG/ML) | 0 | NELARABINE | NELARABINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2023-01-10 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
KINDOS
cder:Array
(
[0] => Array
(
[ApplNo] => 216038
[companyName] => KINDOS
[docInserts] => ["",""]
[products] => [{"drugName":"NELARABINE","activeIngredients":"NELARABINE","strength":"250MG\/50ML (5MG\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/10\/2023","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2023-01-10
)
)