EMCURE PHARMS LTD FDA Approval ANDA 202313

ANDA 202313

EMCURE PHARMS LTD

FDA Drug Application

Application #202313

Application Sponsors

ANDA 202313EMCURE PHARMS LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001SOLUTION;INTRAVENOUS60MG/20ML (3MG/ML)0ADENOSINEADENOSINE
002SOLUTION;INTRAVENOUS90MG/30ML (3MG/ML)0ADENOSINEADENOSINE

FDA Submissions

ORIG1AP2014-09-15

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

EMCURE PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202313
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADENOSINE","activeIngredients":"ADENOSINE","strength":"60MG\/20ML (3MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ADENOSINE","activeIngredients":"ADENOSINE","strength":"90MG\/30ML (3MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/15\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2014-09-15
        )

)

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