NAVINTA LLC FDA Approval ANDA 210594

ANDA 210594

NAVINTA LLC

FDA Drug Application

Application #210594

Application Sponsors

ANDA 210594NAVINTA LLC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTIONEQ 1MG BASE/VIAL0REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
002INJECTABLE;INJECTIONEQ 2MG BASE/VIAL0REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE
003INJECTABLE;INJECTIONEQ 5MG BASE/VIAL0REMIFENTANIL HYDROCHLORIDEREMIFENTANIL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-13STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP
002PrescriptionAP
003PrescriptionAP

CDER Filings

NAVINTA LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210594
            [companyName] => NAVINTA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REMIFENTANIL HYDROCHLORIDE","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 1MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"REMIFENTANIL HYDROCHLORIDE","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 2MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"REMIFENTANIL HYDROCHLORIDE","activeIngredients":"REMIFENTANIL HYDROCHLORIDE","strength":"EQ 5MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-13
        )

)

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