ANDA 202354

HIKMA

FDA Drug Application

Application #202354

Application Sponsors

ANDA 202354

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

ETOMIDATE

ETOMIDATE

FDA Submissions

	ORIG	1	AP	2016-02-25
LABELING; Labeling	SUPPL	2	AP	2018-03-07	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7

TE Codes

001

Prescription

AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202354
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETOMIDATE","activeIngredients":"ETOMIDATE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/25\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/07\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-03-07
        )

)