BRECKENRIDGE FDA Approval ANDA 209325

ANDA 209325

BRECKENRIDGE

FDA Drug Application

Application #209325

Application Sponsors

ANDA 209325BRECKENRIDGE

Marketing Status

Prescription001

Application Products

001CAPSULE;ORAL100MG0MIGLUSTATMIGLUSTAT

FDA Submissions

UNKNOWN; ORIG1AP2022-02-03STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

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
        )

)

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