NDA 208844, held by Bracco. Barium Sulfate.
As of Nov 13, 2026, NDA 208844 (Varibar Pudding), held by Bracco, was first approved by FDA on Oct 14, 2016, with 0 approved supplements and 0 published complete response letters.
VARIBAR PUDDING is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR PUDDING is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 14, 2016 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Varibar Pudding40% · paste;oral | Barium Sulfate | Rx |
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
