Orange Book product · Brand (NDA)
GALLIUM GA 68 GOZETOTIDE
GALLIUM GA-68 GOZETOTIDE
At a glance
Dec 01, 2020
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 01, 2020
5 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
GALLIUM GA-68 GOZETOTIDE
Strength
0.5-5mCi/mL
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 212643
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025GOZELLIXBrand (NDA)
NDA 219592 · TELIX INNOVATIONS
- 2022LOCAMETZBrand (NDA)
NDA 215841 · NOVARTIS
- 2021ILLUCCIXBrand (NDA)
NDA 214032 · TELIX
- 2020GALLIUM GA 68 GOZETOTIDEBrand (NDA)
NDA 212642 · UNIV CA LOS ANGELES
- 2026GALLIUM GA 68 GOZETOTIDEGeneric (ANDA)
ANDA 216410 · RADIOMEDIX
- 2026GALLIUM GA-68 GOZETOTIDEGeneric (ANDA)
ANDA 219189 · IONETIX
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
