Assyro AI

Orange Book product · Brand (NDA)

OMNIPAQUE 350

IOHEXOL

Brand (NDA)NDA 020608RX GE HEALTHCARE

At a glance

Oct 24, 1995

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 24, 1995

    31 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IOHEXOL

Strength

75.5%

Dosage form

SOLUTION

Route

INJECTION, ORAL

TE code

Not listed

Application

NDA 020608

Product number

003

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active ingredient are listed below.

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.