FDA.reportPublic FDA data

Application 212642

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/MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
76394-2642Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCLA Biomedical CyclotronNDACurrent
76394-2642Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCLA Biomedical CyclotronNDACurrent
76394-2642Gallium Ga-68 PSMA-11GALLIUM GA-68 GOZETOTIDEUCLA Biomedical CyclotronNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71355SUPPL2022-06-21
71346SUPPL2022-06-17
69351SUPPL2021-11-18
69348SUPPL2021-11-18
65603ORIG2020-12-16
65486ORIG2020-12-02
65482ORIG2020-12-02