TOBRAMYCIN | N205433 | PULMOFLOW INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Recruiting | Major Extremity Trauma Research Consortium | 600 | 2021-05-07 → 2029-03-31 | |
| Phase 2 | Recruiting | University Hospital, Linkoeping | 1,100 | 2022-04-01 → 2031-12 | |
| N/A | Recruiting | Elute, Inc. | 204 | 2023-08-31 → 2029-12-31 | |
| Phase 1/2 | Completed | Mayo Clinic | 19 | 2018-09-26 → 2021-02-01 | |
| N/A | Completed | McMaster University | 150 | 2010-11 → 2016-03 | |
| Phase 1 | Completed | Novartis | 20 | 2006-04 | |
| Phase 3 | Completed | University Hospital Tuebingen | 26 | 2014-03-11 → 2016-11-25 | |
| Phase 3 | Completed | NTC srl | 808 | 2018-09-03 → 2018-12-19 | |
| Phase 3 | Completed | FDA Office of Orphan Products Development | 200 | 1995-06 → 1998-05 | |
| Phase 3 | Completed | Merck Sharp & Dohme LLC | 743 | 2004-07 → 2005-10 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
Lowest Price
$1082.95
Highest Price
$2577.89
FSS NDCs
2
Big4 NDCs
0
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 24492-0850-56KITABIS PAK | $2577.89 | FSS | PARI Respiratory Equipment, Inc. | 08/31/2026 |
| 70644-0899-99TOBRAMYCIN 300MG/5ML SOLN,INHL,ORAL,5ML,KIT,5 | $1082.95 | FSS | Genericus, Inc. | 12/14/2029 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
4 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 11, 2023 | SUPPL -8 | View Letter (PDF) |
| Feb 13, 2023 | SUPPL -7 | View Letter (PDF) |
| Dec 10, 2019 | SUPPL -5 | View Letter (PDF) |
| Dec 3, 2014 | ORIG -1 | View Letter (PDF) |
| Aug 27, 2014 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.