BUDESONIDE | N205613 | SALIX PHARMACEUTICALS INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1/2 | Active | Vanderbilt University Medical Center | 64 | 2017-08-19 → 2026-12-30 | |
| Phase 4 | Active | University of British Columbia | 20 | 2021-01-07 → 2027-12-31 | |
| Phase 4 | Recruiting | University of British Columbia | 30 | 2018-12-01 → 2025-12-31 | |
| Phase 4 | Recruiting | Gelb, Arthur F., M.D. | 50 | 2007-10 → 2027-06 | |
| Phase 2 | Recruiting | Instituto Nacional de Cancerologia de Mexico | 72 | 2018-09-01 → 2027-12-01 | |
| Phase 4 | Recruiting | Bausch Health Americas, Inc. | 70 | 2023-09-29 → 2027-06 | |
| Phase 4 | Completed | AstraZeneca | 1,900 | 2004-09 → 2006-10 | |
| Phase 1 | Completed | Parc de Salut Mar | 4 | 2018-05-22 → 2018-09-10 | |
| Phase 3 | Completed | AstraZeneca | 3,850 | 2014-07-07 → 2017-08-02 | |
| N/A | Completed | Imperial College London | 10 | 2004-11 → 2006-11 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$136.20
Highest Price
$641.66
FSS NDCs
2
Big4 NDCs
2
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 68682-0658-03BUDESONIDE 2MG/ACTUAT AEROSOL,RTL | $507.54 | FSS | Bausch Health US, LLC | 04/30/2026 |
| 68682-0658-03BUDESONIDE 2MG/ACTUAT AEROSOL,RTL | $136.20 | Big4 | Bausch Health US, LLC | 04/30/2026 |
| 65649-0651-03UCERIS 2MG/ACTUAT RECTAL AEROSOL | $641.66 | FSS | Bausch Health US, LLC | 04/30/2026 |
| 65649-0651-03UCERIS 2MG/ACTUAT RECTAL AEROSOL | $608.78 | Big4 | Bausch Health US, LLC | 04/30/2026 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
21 active API suppliers hold Drug Master Files for this ingredient.
Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.
| Date | Submission | Document |
|---|---|---|
| Apr 10, 2020 | SUPPL -4 | View Letter (PDF) |
| Oct 8, 2014 | ORIG -1 | View Letter (PDF) |
| Sep 17, 2014 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.