BRECKENRIDGE FDA Approval ANDA 210111

ANDA 210111

BRECKENRIDGE

FDA Drug Application

Application #210111

Application Sponsors

ANDA 210111BRECKENRIDGE

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001CAPSULE;ORAL1MG0POMALIDOMIDEPOMALIDOMIDE
002CAPSULE;ORAL2MG0POMALIDOMIDEPOMALIDOMIDE
003CAPSULE;ORAL3MG0POMALIDOMIDEPOMALIDOMIDE
004CAPSULE;ORAL4MG0POMALIDOMIDEPOMALIDOMIDE

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

BRECKENRIDGE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210111
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"1MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"2MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"3MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"POMALIDOMIDE","activeIngredients":"POMALIDOMIDE","strength":"4MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-30
        )

)

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