ANDA 212957

NAVINTA LLC

FDA Drug Application

Application #212957

Application Sponsors

ANDA 212957

NAVINTA LLC

Marketing Status

• Prescription: 002

Application Products

002

POWDER;INTRAVENOUS

EQ 150MG BASE/VIAL

0

FOSAPREPITANT DIMEGLUMINE

FOSAPREPITANT DIMEGLUMINE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-08-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

002

Prescription

AP

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
        )

)