BUDESONIDE | N205613 | SALIX PHARMACEUTICALS INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Active | Dr. Falk Pharma GmbH | 308 | 2021-05-21 → 2028-03 | |
| Phase 1/2 | Active | Vanderbilt University Medical Center | 64 | 2017-08-19 → 2026-12-30 | |
| Phase 3 | Active | AstraZeneca | 310 | 2024-09-30 → 2027-06-25 | |
| Phase 2 | Active | Sanofi | 556 | 2024-11-07 → 2027-07-19 | |
| Phase 2 | Active | University of Calgary | 80 | 2024-03-21 → 2026-12 | |
| Phase 4 | Active | University of British Columbia | 20 | 2021-01-07 → 2027-12-31 | |
| Phase 4 | Active | AstraZeneca | 1,511 | 2024-05-10 → 2027-02-03 | |
| Phase 4 | Active | Calliditas Therapeutics AB | 60 | 2024-12-17 → 2028-02 | |
| Phase 1/2 | Active | Washington University School of Medicine | 60 | 2021-12-16 → 2028-11-30 | |
| Phase 4 | By Invitation | Endeavor Health | 40 | 2026-07-01 → 2028-01-01 |
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 |
|---|---|---|---|---|
| 65649-0651-03UCERIS 2MG/ACTUAT RECTAL AEROSOL | $608.78 | 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 |
| 68682-0658-03BUDESONIDE 2MG/ACTUAT AEROSOL,RTL | $136.20 | Big4 | Bausch Health US, LLC | 04/30/2026 |
| 68682-0658-03BUDESONIDE 2MG/ACTUAT AEROSOL,RTL | $507.54 | FSS | 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.