NDA 212642

UNIV CALIFORNIA LOS ANGELES

FDA Drug Application

Application #212642

Documents

• Label: 2020-12-02
• Letter: 2020-12-02
• Review: 2020-12-16
• Letter: 2021-11-18
• Label: 2021-11-18
• Letter: 2022-06-17
• Label: 2022-06-21

Application Sponsors

NDA 212642

UNIV CALIFORNIA LOS ANGELES

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

18.5MBQ/ML to 185MBQ/ML (0.5MCI/ML to 5MCI/ML

2

GALLIUM Ga 68 PSMA-11

PSMA-11 Ga 68

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-12-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-06-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15

CDER Filings

UNIV CALIFORNIA LOS ANGELES

cder:Array
(
    [0] => Array
        (
            [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
        )

)