PAR PHARM FDA Approval ANDA 205775

ANDA 205775

PAR PHARM

FDA Drug Application

Application #205775

Application Sponsors

ANDA 205775PAR PHARM

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL0.25MG0EVEROLIMUSEVEROLIMUS
002TABLET;ORAL0.5MG0EVEROLIMUSEVEROLIMUS
003TABLET;ORAL0.75MG0EVEROLIMUSEVEROLIMUS
004TABLET;ORAL1MG0EVEROLIMUSEVEROLIMUS

FDA Submissions

UNKNOWN; ORIG1AP2021-10-18STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

PAR PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205775
            [companyName] => PAR PHARM
            [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"},{"drugName":"EVEROLIMUS","activeIngredients":"EVEROLIMUS","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/18\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-18
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.