ANDA 203428

EMCURE PHARMS LTD

FDA Drug Application

Application #203428

Application Sponsors

ANDA 203428

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

FUROSEMIDE

FUROSEMIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2014-08-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2018-03-05	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	8	Null	15

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203428
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"FUROSEMIDE","activeIngredients":"FUROSEMIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/05\/2018","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-03-05
        )

)