Orange Book product · Brand (NDA)

E-Z-CAT DRY

BARIUM SULFATE

Brand (NDA)NDA 208036DISCN BRACCO

View BARIUM SULFATE family Open on FDA Orange Book

At a glance

Jan 03, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jan 03, 2017
9 yr 7 mo ago
Today

Pharmaceutical detail

Active ingredient

BARIUM SULFATE

Strength

40%

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 208036

Product number

003

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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.

E-Z-DISKBrand (NDA)
NDA 219840 · BRACCO
2025
ENTERO VU 24%Brand (NDA)
NDA 208143 · BRACCO
2020
VARIBAR PUDDINGBrand (NDA)
NDA 208844 · BRACCO
2016

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.

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

Book a Demo