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FDA Orange Book · active-ingredient family

Barium sulfate

Barium sulfate is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:E-Z-DISK · NDA 219840

4

Brand (NDA)

0

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · for suspension, paste, suspension, tablet

ProductApplicantApplicationTEApproved
E-Z-DISKRLDBRACCONDA 219840Aug 01, 2025
ENTERO VU 24%RLD×8BRACCONDA 208143May 29, 2020
E-Z-CAT DRYRLD×4BRACCONDA 208036Jan 03, 2017
VARIBAR PUDDINGBRACCONDA 208844Oct 14, 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.

Barium sulfate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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