ANDA 212262

SUNGEN PHARMA

FDA Drug Application

Application #212262

Application Sponsors

ANDA 212262

SUNGEN PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

4MG

0

METHYLPREDNISOLONE

METHYLPREDNISOLONE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-06-27

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

SUNGEN PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212262
            [companyName] => SUNGEN PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHYLPREDNISOLONE","activeIngredients":"METHYLPREDNISOLONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/27\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-06-27
        )

)