Active ingredient
Gozetotide
4 finished FDA listings contain Gozetotide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- GALLIUM GA-68 GOZETOTIDE, GOZETOTIDE, PSMA-HBED-CC
- Dosage forms
- Injection, Powder, Lyophilized, For Solution, Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 4
- Strengths listed
- 25 ug/1 · 5 mci/ml
- Brand names in FDA listings
- Gallium Ga-68 Psma-11, Locametz
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2588949
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 212642 | UNIV CA LOS ANGELES | 2020-12-01 | 1 |
| NDA 212643 | UNIV OF CA SAN FRAN | 2020-12-01 | 1 |
| NDA 215841 | NOVARTIS | 2022-03-23 | 1 |
| ANDA 219189 | IONETIX | 2026-05-14 | 1 |
Official labeling on DailyMed
- GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [IONETIX CORPORATION] · version 2 · 2026-05-21
- LOCAMETZ (KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] · version 1 · 2026-01-16
- GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [UCSF RADIOPHARMACEUTICAL FACILITY] · version 8 · 2025-12-16
- GALLIUM GA-68 PSMA-11 (GALLIUM GA-68 GOZETOTIDE) INJECTION, SOLUTION [UCLA BIOMEDICAL CYCLOTRON] · version 6 · 2024-11-25
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.