Documents
Application Sponsors
NDA 212643 | UNIV CALIFORNIA LOS ANGELES | |
Marketing Status
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
CDER Filings
UNIV CALIFORNIA LOS ANGELES
cder:Array
(
[0] => Array
(
[ApplNo] => 212643
[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\\\/212643s000lbl.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\\\/212643s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212643Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-12-01
)
)