Orange Book product · Generic (ANDA)
GALLIUM GA 68 EDOTREOTIDE
GALLIUM GA-68 EDOTREOTIDE
Generic (ANDA)ANDA 218845TE APRX METHODIST
At a glance
Oct 10, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 10, 2025
8 mo ago
Today
Pharmaceutical detail
Active ingredient
GALLIUM GA-68 EDOTREOTIDE
Strength
0.5-4mCi/ML
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 218845
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GALLIUM GA-68 EDOTREOTIDE
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.

