ANDA 202359

EMCURE PHARMS LTD

FDA Drug Application

Application #202359

Application Sponsors

ANDA 202359

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 150MG BASE/VIAL

0

COLISTIMETHATE SODIUM

COLISTIMETHATE SODIUM

FDA Submissions

	ORIG	1	AP	2012-09-28
LABELING; Labeling	SUPPL	2	AP	2016-02-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-03-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202359
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"COLISTIMETHATE SODIUM","activeIngredients":"COLISTIMETHATE SODIUM","strength":"EQ 150MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/28\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"02\/10\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2016-02-10
        )

)