ANDA 202274

EMCURE PHARMS LTD

FDA Drug Application

Application #202274

Application Sponsors

ANDA 202274

EMCURE PHARMS LTD

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5GM BASE/VIAL

0

VANCOMYCIN HYDROCHLORIDE

VANCOMYCIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2013-10-31
LABELING; Labeling	SUPPL	3	AP	2020-09-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-05-25	STANDARD

Submissions Property Types

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

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202274
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/31\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/22\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/22\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-22
        )

)