ANDA 209821

EDENBRIDGE PHARMS

FDA Drug Application

Application #209821

Application Sponsors

ANDA 209821

EDENBRIDGE PHARMS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

0

MIGLUSTAT

MIGLUSTAT

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-06

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

EDENBRIDGE PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209821
            [companyName] => EDENBRIDGE PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MIGLUSTAT","activeIngredients":"MIGLUSTAT","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-06
        )

)