ANDA 203662

HIKMA

FDA Drug Application

Application #203662

Application Sponsors

ANDA 203662

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1MG BASE/ML

0

NOREPINEPHRINE BITARTRATE

NOREPINEPHRINE BITARTRATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-11-07	STANDARD
LABELING; Labeling	SUPPL	3	AP	2021-02-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-02-26	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203662
            [companyName] => HIKMA
            [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":"11\/07\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-07
        )

)