NDA 208036, held by Bracco. Barium Sulfate.
As of Nov 13, 2026, NDA 208036 (E-Z-Hd, E-Z-Paque, E-Z-Cat Dry), held by Bracco, was first approved by FDA on Jan 11, 2016, with 4 approved supplements and 0 published complete response letters.
VARIBAR THIN LIQUID is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN LIQUID is a radiopaque contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients
| Apr 30, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 7, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jan 3, 2017 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 11, 2016 | Original applicationTYPE 7 · Standard review | Approved |
| E-Z-Hd98% · for suspension;oral | Barium Sulfate | RxReference drug |
| E-Z-Paque96% · for suspension;oral | Barium Sulfate | RxReference drug |
| E-Z-Cat Dry40% · for suspension;oral | Barium Sulfate | DiscontinuedReference drug |
| Varibar Thin Liquid81% · for suspension;oral | Barium Sulfate | RxReference drug |
| Apr 30, 2019 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 7, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 8, 2017 | Supplement 6Labeling · Standard review | Approved | |
| Jan 3, 2017 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 11, 2016 | Original applicationTYPE 7 · Standard review | Approved |
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
