ANDA 209097

LUPIN LTD

FDA Drug Application

Application #209097

Application Sponsors

ANDA 209097

LUPIN LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	2MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE
002	TABLET;ORAL	4MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE
003	TABLET;ORAL	8MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE
004	TABLET;ORAL	16MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE
005	TABLET;ORAL	32MG	0	METHYLPREDNISOLONE	METHYLPREDNISOLONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-02-22

STANDARD

Submissions Property Types

ORIG

1

Null

7

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
        )

)