ANDA 213729

NOVITIUM PHARMA

FDA Drug Application

Application #213729

Documents

• Letter: 2021-12-20

Application Sponsors

ANDA 213729

NOVITIUM PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FOR SUSPENSION;ORAL

200MG

0

CARGLUMIC ACID

CARGLUMIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NOVITIUM PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213729
            [companyName] => NOVITIUM PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CARGLUMIC ACID","activeIngredients":"CARGLUMIC ACID","strength":"200MG","dosageForm":"TABLET, FOR SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-10-13
        )

)