TERBINAFINE HYDROCHLORIDE | N021124 | KARO HEALTHCARE INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 3 | Completed | Novartis | 1,029 | 2007-03 → 2009-01 | |
| Phase 1 | Completed | Teva Pharmaceuticals USA | 22 | 2002-01 → 2002-01 | |
| N/A | Completed | Roxane Laboratories | 30 | 2004-03 → 2004-04 | |
| Phase 2 | Completed | Nitric BioTherapeutics, Inc | 25 | 2011-12 → 2012-04 | |
| Phase 2 | Completed | Merck Sharp & Dohme LLC | 218 | 2007-06 → 2008-12 | |
| Phase 2 | Completed | MediQuest Therapeutics | 75 | 2005-09 | |
| Phase 1 | Completed | Mylan Pharmaceuticals Inc | 36 | 2004-02 → 2004-03 | |
| Phase 1 | Completed | NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.) | 56 | 2005-02 → 2005-12 | |
| Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 36 | 2002-01 → 2002-03 | |
| Phase 2 | Completed | Nitric BioTherapeutics, Inc | 168 | 2010-05 → 2012-06 |
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 |
|---|---|---|
| Oct 23, 2018 | SUPPL -16 | View Letter (PDF) |
| Nov 15, 2013 | SUPPL -13 | View Letter (PDF) |
| Mar 26, 2012 | SUPPL -11 | View Letter (PDF) |
| Feb 22, 2010 | SUPPL -9 | View Letter (PDF) |
| Jun 17, 2009 | SUPPL -8 | View Letter (PDF) |
| Jul 31, 2008 | SUPPL -7 | View Letter (PDF) |
| Mar 17, 2000 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.