Assyro AI

Orange Book product · Generic (ANDA)

IOBENGUANE I-123

IOBENGUANE SULFATE I-123

Generic (ANDA)ANDA 213637DISCN BWXT MEDCL

At a glance

Dec 09, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 09, 2024

    1 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IOBENGUANE SULFATE I-123

Strength

10mCi/5ML (2mCi/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

ANDA 213637

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of IOBENGUANE SULFATE I-123

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.