TOBRAMYCIN | N205433 | PULMOFLOW INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 4 | Completed | Bausch & Lomb Incorporated | 137 | 2008-06 → 2010-05 | |
| N/A | Completed | Sun Yat-sen University | 75 | 2015-09 → 2016-04 | |
| Phase 2 | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 98 | 2000-02 → 2002-02 | |
| Phase 3 | Completed | Laboratoires Thea | 286 | 2008-12 → 2011-02 | |
| Phase 4 | Completed | Zhongshan Ophthalmic Center, Sun Yat-sen University | 20 | 2016-11-01 → 2018-02-01 | |
| Phase 4 | Completed | Washington University School of Medicine | 20 | 2020-02-14 → 2020-11-01 | |
| 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 1/2 | Completed | Mayo Clinic | 19 | 2018-09-26 → 2021-02-01 | |
| Phase 3 | Completed | Merck Sharp & Dohme LLC | 743 | 2004-07 → 2005-10 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$1082.95
Highest Price
$2577.89
FSS NDCs
2
Big4 NDCs
0
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 70644-0899-99TOBRAMYCIN 300MG/5ML SOLN,INHL,ORAL,5ML,KIT,5 | $1082.95 | FSS | Genericus, Inc. | 12/14/2029 |
| 24492-0850-56KITABIS PAK | $2577.89 | FSS | PARI Respiratory Equipment, Inc. | 08/31/2026 |
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.