NAVINTA LLC FDA Approval ANDA 212957

ANDA 212957

NAVINTA LLC

FDA Drug Application

Application #212957

Application Sponsors

ANDA 212957NAVINTA LLC

Marketing Status

Prescription002

Application Products

002POWDER;INTRAVENOUSEQ 150MG BASE/VIAL0FOSAPREPITANT DIMEGLUMINEFOSAPREPITANT DIMEGLUMINE

FDA Submissions

UNKNOWN; ORIG1AP2020-08-20STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

002PrescriptionAP

CDER Filings

NAVINTA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212957
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FOSAPREPITANT DIMEGLUMINE","activeIngredients":"FOSAPREPITANT DIMEGLUMINE","strength":"EQ 150MG BASE\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-08-20
        )

)

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