Application Sponsors
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
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
)
)