NDA 213227

RADIOMEDIX INC

FDA Drug Application

Application #213227

Documents

• Letter: 2020-09-04
• Review: 2020-09-16
• Label: 2020-09-22
• Letter: 2021-12-27
• Label: 2021-12-27

Application Sponsors

NDA 213227

RADIOMEDIX INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

148 MBq (4 mCi) (37 MBq (1mCi) per 1ML)

0

DETECTNET

COPPER CU 64 DOTATATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-09-03

PRIORITY

Submissions Property Types

ORIG

1

Null

7

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
        )

)