ANDA 210594

NAVINTA LLC

FDA Drug Application

Application #210594

Application Sponsors

ANDA 210594

NAVINTA LLC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	EQ 1MG BASE/VIAL	0	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
002	INJECTABLE;INJECTION	EQ 2MG BASE/VIAL	0	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE
003	INJECTABLE;INJECTION	EQ 5MG BASE/VIAL	0	REMIFENTANIL HYDROCHLORIDE	REMIFENTANIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

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
        )

)