ANDA 210839

AMNEAL

FDA Drug Application

Application #210839

Application Sponsors

ANDA 210839

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1MG BASE/ML

0

NOREPINEPHRINE BITARTRATE

NOREPINEPHRINE BITARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-12-17	STANDARD
LABELING; Labeling	SUPPL	6	AP	2020-10-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210839
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"NOREPINEPHRINE BITARTRATE","activeIngredients":"NOREPINEPHRINE BITARTRATE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/17\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-12-17
        )

)