Application Sponsors
Marketing Status
Application Products
001 | CAPSULE;ORAL | 100MG | 0 | MIGLUSTAT | MIGLUSTAT |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2022-02-03 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
BRECKENRIDGE
cder:Array
(
[0] => Array
(
[ApplNo] => 209325
[companyName] => BRECKENRIDGE
[docInserts] => ["",""]
[products] => [{"drugName":"MIGLUSTAT","activeIngredients":"MIGLUSTAT","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/03\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-02-03
)
)