TERBINAFINE HYDROCHLORIDE | N020980 | KARO HEALTHCARE INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| N/A | Not Yet Recruiting | Assiut University | 97 | 2026-10-10 → 2028-02-10 | |
| Phase 2 | Not Yet Recruiting | Guangdong Provincial People's Hospital | 208 | 2026-09-01 → 2028-05-01 | |
| Phase 2 | Recruiting | Swiss Cancer Institute | 42 | 2026-04-24 → 2030-10 | |
| Phase 3 | Completed | Novartis | 720 | 2004-07 → 2006-04 | |
| Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 18 | 2002-01 → 2002-03 | |
| Phase 3 | Completed | Novartis Pharmaceuticals | 526 | 2006-12 → 2008-06 | |
| N/A | Completed | Chittagong Medical College | 138 | 2021-03-01 → 2021-08-31 | |
| Phase 3 | Completed | Novartis Pharmaceuticals | 720 | 2004-06 | |
| Phase 1 | Completed | Teva Pharmaceuticals USA | 22 | 2002-01 → 2002-01 | |
| N/A | Completed | Roxane Laboratories | 30 | 2004-03 → 2004-04 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
18 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 |
|---|---|---|
| Jul 18, 2019 | SUPPL -12 | View Letter (PDF) |
| Mar 26, 2012 | SUPPL -9 | View Letter (PDF) |
| Jul 27, 2007 | SUPPL -5 | View Letter (PDF) |
| Jun 8, 2004 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.