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Orange Book product · Generic (ANDA)

GALLIUM GA 68 GOZETOTIDE

GALLIUM GA-68 GOZETOTIDE

Generic (ANDA)ANDA 216410TE APRX RADIOMEDIX

At a glance

Jun 08, 2026

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 08, 2026

    11 d ago

  2. Today

Pharmaceutical detail

Active ingredient

GALLIUM GA-68 GOZETOTIDE

Strength

0.5-5mCi/ML

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

AP

Application

ANDA 216410

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 GOZETOTIDE

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.