UNIV CALIFORNIA LOS ANGELES FDA Approval NDA 212642

NDA 212642

UNIV CALIFORNIA LOS ANGELES

FDA Drug Application

Application #212642

Documents

Label2020-12-02
Letter2020-12-02
Review2020-12-16

Application Sponsors

NDA 212642UNIV CALIFORNIA LOS ANGELES

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION18.5MBQ/ML to 185MBQ/ML (0.5MCI/ML to 5MCI/ML2GALLIUM Ga 68 PSMA-11PSMA-11 Ga 68

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-12-01STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

UNIV CALIFORNIA LOS ANGELES
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            [ApplNo] => 212642
            [companyName] => UNIV CALIFORNIA LOS ANGELES
            [docInserts] => ["",""]
            [products] => [{"drugName":"GALLIUM Ga 68 PSMA-11","activeIngredients":"PSMA-11 Ga 68","strength":"18.5MBQ\/ML to 185MBQ\/ML (0.5MCI\/ML to 5MCI\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212642s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/01\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212642s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212642Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-12-01
        )

)

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