ANDA 214102

NOVITIUM PHARMA

FDA Drug Application

Application #214102

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 214102

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

20MG/5ML

0

VALSARTAN

VALSARTAN

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-11-02

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214102
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"VALSARTAN","activeIngredients":"VALSARTAN","strength":"20MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-02
        )

)