FDA.reportPublic FDA data

Application 212643

Type
NDA
Sponsor
UNIV CALIFORNIA LOS ANGELES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALLIUM GA 68 PSMA-11PSMA-11 Ga 68INJECTABLE;INJECTION18.5MBQ/ML to 185MBQ/ML(0.5MCI/ML to 5MCI/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24275-0525Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCSF Radiopharmaceutical FacilityNDACurrent
24275-0525Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCSF Radiopharmaceutical FacilityNDACurrent
24275-0525Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCSF Radiopharmaceutical FacilityNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71354SUPPL2022-06-21
69350SUPPL2021-11-18
69349SUPPL2021-11-18
65605ORIG2020-12-17
65485ORIG2020-12-02
65483ORIG2020-12-02