RADIOMEDIX INC FDA Approval NDA 213227

NDA 213227

RADIOMEDIX INC

FDA Drug Application

Application #213227

Documents

Letter2020-09-04
Review2020-09-16

Application Sponsors

NDA 213227RADIOMEDIX INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION148 MBq (4 mCi) (37 MBq (1mCi) per 1ML)0DETECTNETCOPPER CU 64 DOTATATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-09-03PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

RADIOMEDIX INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213227
            [companyName] => RADIOMEDIX INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DETECTNET","activeIngredients":"COPPER CU 64 DOTATATE","strength":"148 MBq (4 mCi) (37 MBq (1mCi) per 1ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/03\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213227Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-03
        )

)

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