ANDA 210985

NOVAST LABS

FDA Drug Application

Application #210985

Application Sponsors

ANDA 210985

NOVAST LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

4MG

0

METHYLPREDNISOLONE

METHYLPREDNISOLONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-01-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

NOVAST LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210985
            [companyName] => NOVAST LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/09\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-01-09
        )

)