Orange Book product · Brand (NDA)
GALLIUM GA 68 EDOTREOTIDE
GALLIUM GA-68 EDOTREOTIDE
At a glance
Aug 21, 2019
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 21, 2019
6 yr 11 mo ago
Today
Exclusivity ends · ODE-383
Orphan-drug exclusivity (7 years)
Aug 21, 2026
in 2 mo
Exclusivity ends · W
Exclusivity withdrawal / change
Aug 21, 2026
in 2 mo
Pharmaceutical detail
Active ingredient
GALLIUM GA-68 EDOTREOTIDE
Strength
0.5-4mCi/ML
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 210828
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.
Marketing exclusivity (2)
- ODE-383Orphan-drug exclusivity (7 years)
Aug 21, 2026
in 2 mo
- WExclusivity withdrawal / change
Aug 21, 2026
in 2 mo
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.
