AMNEAL FDA Approval ANDA 207481

ANDA 207481

AMNEAL

FDA Drug Application

Application #207481

Application Sponsors

ANDA 207481AMNEAL

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL4MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE
002TABLET;ORAL8MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE
003TABLET;ORAL16MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE
004TABLET;ORAL32MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE

FDA Submissions

UNKNOWN; ORIG1AP2021-09-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

AMNEAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207481
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"32MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/21\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-21
        )

)

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