ANDA 213395

NAVINTA LLC

FDA Drug Application

Application #213395

Application Sponsors

ANDA 213395

NAVINTA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, FOR SUSPENSION;ORAL

200MG

0

CARGLUMIC ACID

CARGLUMIC ACID

FDA Submissions

UNKNOWN;

ORIG

1

AP

2022-06-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

NAVINTA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213395
            [companyName] => NAVINTA LLC
            [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":"CARGLUMIC ACID","submission":"CARGLUMIC ACID","actionType":"200MG","submissionClassification":"TABLET, FOR SUSPENSION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)