Assyro AI

Orange Book product · Brand (NDA)

ULTRAVIST 370

IOPROMIDE

Brand (NDA)NDA 020220RX BAYER HLTHCARE

At a glance

May 10, 1995

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 10, 1995

    31 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IOPROMIDE

Strength

76.9%

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 020220

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this 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.