BRECKENRIDGE FDA Approval ANDA 205432

ANDA 205432

BRECKENRIDGE

FDA Drug Application

Application #205432

Application Sponsors

ANDA 205432BRECKENRIDGE

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL0.25MG0EVEROLIMUSEVEROLIMUS
002TABLET;ORAL0.5MG0EVEROLIMUSEVEROLIMUS
003TABLET;ORAL0.75MG0EVEROLIMUSEVEROLIMUS

FDA Submissions

UNKNOWN; ORIG1AP2021-05-20STANDARD

Submissions Property Types

ORIG1Null1

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

BRECKENRIDGE
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205432
            [companyName] => BRECKENRIDGE
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/20\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-20
        )

)

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