TESTOSTERONE | N021543 | AUXILIUM PHARMACEUTICALS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Active | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 15 | 2022-03-07 → 2026-12-04 | |
| Phase 2 | Active | Brigham and Women's Hospital | 30 | 2025-02-15 → 2027-12-01 | |
| Phase 2 | Active | City of Hope Medical Center | 11 | 2004-03-11 → 2024-10-15 | |
| Phase 2 | Active | Seattle Institute for Biomedical and Clinical Research | 230 | 2021-01-12 → 2026-11 | |
| Phase 1 | Active | Roswell Park Cancer Institute | 3 | 2024-12-19 → 2028-03-09 | |
| Phase 2/3 | Not Yet Recruiting | VA Office of Research and Development | 300 | 2027-10-01 → 2032-03-31 | |
| N/A | Not Yet Recruiting | The University of Texas Health Science Center, Houston | 150 | 2027-01-01 → 2028-03-30 | |
| Phase 2 | Not Yet Recruiting | Transdermal Delivery Solutions Corp | 96 | 2027-01-05 → 2027-12 | |
| Phase 2 | Not Yet Recruiting | Transdermal Delivery Solutions Corp | 48 | 2027-06 → 2028-02 | |
| Phase 2/3 | Not Yet Recruiting | ECOG-ACRIN Cancer Research Group | 432 | 2027-01-06 → 2030-03-31 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
11 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 |
|---|---|---|
| Oct 27, 2016 | SUPPL -12 | View Letter (PDF) |
| May 13, 2015 | SUPPL -11 | View Letter (PDF) |
| Jun 23, 2014 | SUPPL -10 | View Letter (PDF) |
| Mar 25, 2014 | SUPPL -9 | View Letter (PDF) |
| Nov 8, 2004 | SUPPL -2 | View Letter (PDF) |
| Nov 28, 2003 | SUPPL -1 | View Letter (PDF) |
| Jun 22, 2003 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.