Assyro AI

Orange Book product · Generic (ANDA)

IOHEXOL

IOHEXOL

Generic (ANDA)ANDA 217737TE APRX AMNEAL

At a glance

Nov 13, 2025

Approved

Generic (ANDA)

Application

AP

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Nov 13, 2025

    7 mo ago

  2. Today

  3. Exclusivity ends · CGT

    FDA marketing exclusivity

    Jul 26, 2026

    in 1 mo

Pharmaceutical detail

Active ingredient

IOHEXOL

Strength

64.7%

Dosage form

SOLUTION

Route

INJECTION, ORAL, RECTAL

TE code

AP

Application

ANDA 217737

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of IOHEXOL

Marketing exclusivity (1)

  • CGTFDA marketing exclusivity

    Jul 26, 2026

    in 1 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.

Agent CTA Background

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