ANDA 215647

NOVITIUM PHARMA

FDA Drug Application

Application #215647

Application Sponsors

ANDA 215647

NOVITIUM PHARMA

Marketing Status

• None (Tentative Approval): 001

FDA Submissions

UNKNOWN;

ORIG

1

TA

2023-01-10

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215647
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"L-GLUTAMINE","activeIngredients":"L-GLUTAMINE","strength":"5G","dosageForm":"POWDER;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/10\/2023","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2023-01-10
        )

)