INTL MEDICATION SYS FDA Approval NDA 211363

NDA 211363

INTL MEDICATION SYS

FDA Drug Application

Application #211363

Documents

Letter2022-08-16
Label2022-08-15

Application Sponsors

NDA 211363INTL MEDICATION SYS

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION1MG/10ML(0.1MG/ML)0EPINEPHRINEEPINEPHRINE

FDA Submissions

TYPE 7; Type 7 - Drug Already Marketed without Approved NDAORIG1AP2022-08-15STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

INTL MEDICATION SYS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211363
            [companyName] => INTL MEDICATION SYS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EPINEPHRINE","activeIngredients":"EPINEPHRINE","strength":"1MG\/10ML(0.1MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 7 - Drug Already Marketed without Approved NDA","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/211363Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-08-15
        )

)

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