ANDA 204040

EMCURE PHARMS LTD

FDA Drug Application

Application #204040

Application Sponsors

ANDA 204040

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 250MG BASE/ML

0

AMIKACIN SULFATE

AMIKACIN SULFATE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2013-12-12
LABELING; Labeling	SUPPL	5	AP	2019-12-13	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-12-13	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-12-13	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	5	Null	7
SUPPL	10	Null	7
SUPPL	14	Null	7

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204040
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMIKACIN SULFATE","activeIngredients":"AMIKACIN SULFATE","strength":"EQ 250MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/12\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"12\/13\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/14\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-12-13
        )

)