Assyro AI

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

  1. Approval

    FDA approval date of this drug product.

    Oct 10, 2025

    8 mo ago

  2. 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 family

Generic (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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.