ANDA 204618

EMCURE PHARMS LTD

FDA Drug Application

Application #204618

Application Sponsors

ANDA 204618

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

2MG/ML

0

ETOMIDATE

ETOMIDATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-08-13
LABELING; Labeling	SUPPL	9	AP	2018-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	9	Null	7

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204618
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ETOMIDATE","activeIngredients":"ETOMIDATE","strength":"2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/13\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/08\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-03-08
        )

)