ANDA 204756

EMCURE PHARMS LTD

FDA Drug Application

Application #204756

Application Sponsors

ANDA 204756

EMCURE PHARMS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

EQ 5MG BASE/ML

0

METOCLOPRAMIDE

METOCLOPRAMIDE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2013-12-20

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001

Prescription

AP

CDER Filings

EMCURE PHARMS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204756
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"METOCLOPRAMIDE","activeIngredients":"METOCLOPRAMIDE HYDROCHLORIDE","strength":"EQ 5MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"12\/20\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2013-12-20
        )

)