Gallium Ga-68 PSMA-11
These highlights do not include all the information needed to use GALLIUM GA 68 GOZETOTIDE INJECTION safely and effectively. See full prescribing information for GALLIUM GA 68 GOZETOTIDE INJECTION. GALLIUM GA 68 GOZETOTIDE INJECTION, for intravenous use Initial U.S. Approval: 2020 ( Gozetotide is also known as PSMA-11)
Approved
Approval ID
7744bafb-755e-29a2-e053-2991aa0a86a9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2022
Manufacturers
FDA
UCLA Biomedical Cyclotron
DUNS: 967798120
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GALLIUM GA-68 GOZETOTIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76394-2642
Application NumberNDA212642
Product Classification
M
Marketing Category
C73594
G
Generic Name
GALLIUM GA-68 GOZETOTIDE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 1, 2022
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GALLIUM GA-68 GOZETOTIDEActive
Quantity: 5 mCi in 1 mL
Code: ZJ0EKR6M10
Classification: ACTIB