NAVINTA LLC FDA Approval ANDA 213395

ANDA 213395

NAVINTA LLC

FDA Drug Application

Application #213395

Application Sponsors

ANDA 213395NAVINTA LLC

Marketing Status

Prescription001

Application Products

001TABLET, FOR SUSPENSION;ORAL200MG0CARGLUMIC ACIDCARGLUMIC ACID

FDA Submissions

UNKNOWN; ORIG1AP2022-06-22STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB

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
        )

)

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