NDA 219840, held by Bracco. Barium Sulfate.
As of Nov 13, 2026, NDA 219840 (E-Z-Disk), held by Bracco, was first approved by FDA on Aug 1, 2025, with 0 approved supplements and 0 published complete response letters.
E-Z-DISK is indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2025 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| E-Z-Disk700MG · tablet;oral | Barium Sulfate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
