BRECKENRIDGE FDA Approval ANDA 209330

ANDA 209330

BRECKENRIDGE

FDA Drug Application

Application #209330

Documents

Letter2021-07-07

Application Sponsors

ANDA 209330BRECKENRIDGE

Marketing Status

Prescription001
Prescription002

Application Products

001POWDER;INTRAVENOUS10MG/VIAL0CARFILZOMIBCARFILZOMIB
002POWDER;INTRAVENOUS60MG/VIAL0CARFILZOMIBCARFILZOMIB

FDA Submissions

UNKNOWN; ORIG1AP2021-06-11STANDARD
UNKNOWN; ORIG2TA2021-06-11STANDARD

Submissions Property Types

ORIG1Null7
ORIG2Null31

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

BRECKENRIDGE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209330
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"10MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CARFILZOMIB","activeIngredients":"CARFILZOMIB","strength":"60MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/11\/2021","submission":"ORIG-2","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/11\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-11
        )

)

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