Application Sponsors
ANDA 207991 | ACCORD HLTHCARE INC | |
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | CAPSULE;ORAL | 0.5MG | 0 | FINGOLIMOD | FINGOLIMOD |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2019-04-19 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ACCORD HLTHCARE INC
cder:Array
(
[0] => Array
(
[ApplNo] => 207991
[companyName] => ACCORD HLTHCARE INC
[docInserts] => ["",""]
[products] => [{"drugName":"FINGOLIMOD","activeIngredients":"FINGOLIMOD","strength":"0.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"04\/19\/2019","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2019-04-19
)
)