LUPIN LTD FDA Approval ANDA 209097

ANDA 209097

LUPIN LTD

FDA Drug Application

Application #209097

Application Sponsors

ANDA 209097LUPIN LTD

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005

Application Products

001TABLET;ORAL2MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE
002TABLET;ORAL4MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE
003TABLET;ORAL8MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE
004TABLET;ORAL16MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE
005TABLET;ORAL32MG0METHYLPREDNISOLONEMETHYLPREDNISOLONE

FDA Submissions

UNKNOWN; ORIG1AP2019-02-22STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

LUPIN LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209097
            [companyName] => LUPIN LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"16MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"32MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/22\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-02-22
        )

)

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