EMCURE PHARMS LTD FDA Approval ANDA 202951

ANDA 202951

EMCURE PHARMS LTD

FDA Drug Application

Application #202951

Application Sponsors

ANDA 202951EMCURE PHARMS LTD

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INTRAVENOUSEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)0PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDE
002INJECTABLE;INTRAVENOUSEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)0PALONOSETRON HYDROCHLORIDEPALONOSETRON HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2021-06-29

Submissions Property Types

ORIG1Null15

TE Codes

002PrescriptionAP

CDER Filings

EMCURE PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202951
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.075MG BASE\/1.5ML (EQ 0.05MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PALONOSETRON HYDROCHLORIDE","activeIngredients":"PALONOSETRON HYDROCHLORIDE","strength":"EQ 0.25MG BASE\/5ML (EQ 0.05MG BASE\/ML)","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/29\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-29
        )

)

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