TESTOSTERONE | N021543 | AUXILIUM PHARMACEUTICALS LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 4 | Active | Esbjerg Hospital - University Hospital of Southern Denmark | 64 | 2020-12-17 → 2025-12 | |
| Phase 2 | Active | City of Hope Medical Center | 11 | 2004-03-11 → 2024-10-15 | |
| Phase 2 | Not Yet Recruiting | Transdermal Delivery Solutions Corp | 48 | 2026-06 → 2027-02 | |
| Phase 2 | Not Yet Recruiting | Transdermal Delivery Solutions Corp | 96 | 2027-01-05 → 2027-12 | |
| Phase 2 | Recruiting | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 150 | 2020-08-19 → 2027-07 | |
| N/A | Recruiting | Memorial Sloan Kettering Cancer Center | 300 | 2003-02 → 2027-02 | |
| Phase 2 | Recruiting | University Hospital, Strasbourg, France | 40 | 2019-10-29 → 2027-12 | |
| Phase 2 | Recruiting | Seattle Institute for Biomedical and Clinical Research | 230 | 2021-01-12 → 2026-11-01 | |
| Phase 2 | Recruiting | Seattle Institute for Biomedical and Clinical Research | 240 | 2021-03-22 → 2027-01-30 | |
| Phase 4 | Recruiting | Alexandra Kautzky-Willer | 32 | 2022-01-25 → 2028-12 |
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.