LOCAMETZ
These highlights do not include all the information needed to use LOCAMETZ safely and effectively. See full prescribing information for LOCAMETZ. LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection), for intravenous use Initial U.S. Approval: 2020
Approved
Approval ID
1ea62b65-8138-4a88-8a33-4060ececa42f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
Advanced Accelerator Applications USA, Inc
DUNS: 051714355
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
kit for the preparation of gallium Ga 68 gozetotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69488-017
Application NumberNDA215841
Product Classification
M
Marketing Category
C73594
G
Generic Name
kit for the preparation of gallium Ga 68 gozetotide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 23, 2022
FDA Product Classification
INGREDIENTS (6)
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GENTISIC ACIDInactive
Code: VP36V95O3T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
GOZETOTIDEActive
Quantity: 25 ug in 1 1
Code: 9AG41L3AOQ
Classification: ACTIB