Application Sponsors
ANDA 206863 | ACCORD HLTHCARE | |
Marketing Status
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | 10MG | 0 | DALFAMPRIDINE | DALFAMPRIDINE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-07-11 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ACCORD HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 206863
[companyName] => ACCORD HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"DALFAMPRIDINE","activeIngredients":"DALFAMPRIDINE","strength":"10MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/11\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-07-11
)
)