EMCURE PHARMS LTD FDA Approval ANDA 213806

ANDA 213806

EMCURE PHARMS LTD

FDA Drug Application

Application #213806

Application Sponsors

ANDA 213806EMCURE PHARMS LTD

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION300MG/VIAL0PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATE

FDA Submissions

UNKNOWN; ORIG1AP2021-01-07STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP

CDER Filings

EMCURE PHARMS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213806
            [companyName] => EMCURE PHARMS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTAMIDINE ISETHIONATE","activeIngredients":"PENTAMIDINE ISETHIONATE","strength":"300MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-07
        )

)

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