AVID RADIOPHARMS INC FDA Approval NDA 212123

NDA 212123

AVID RADIOPHARMS INC

FDA Drug Application

Application #212123

Documents

Label2020-05-29
Letter2020-06-01
Review2020-07-16

Application Sponsors

NDA 212123AVID RADIOPHARMS INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION370MBQ(10MCI)2TAUVIDFLORTAUCIPIR F18
002SOLUTION;INTRAVENOUS50ML (8.1-51mCi/ML)1TAUVIDFLORTAUCIPIR F-18

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-05-28PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

AVID RADIOPHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212123
            [companyName] => AVID RADIOPHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TAUVID","activeIngredients":"FLORTAUCIPIR F-18","strength":"30ML (8.1-51mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"TAUVID","activeIngredients":"FLORTAUCIPIR F-18","strength":"50ML (8.1-51mCi\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212123s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/28\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212123s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212123Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-05-28
        )

)

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