Assyro AI

Orange Book product · Brand (NDA)

ENTERO VU 24%

BARIUM SULFATE

Brand (NDA)NDA 208143RX BRACCO

At a glance

May 29, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 29, 2020

    6 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

BARIUM SULFATE

Strength

24%

Dosage form

SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 208143

Product number

008

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.