KETOPROFEN | N022470 | NOVARTIS CONSUMER HEALTH INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 4 | Completed | Pfizer | 340 | 2007-06 → 2009-06 | |
| Phase 4 | Completed | Lithuanian University of Health Sciences | 54 | 2012-11 → 2017-03 | |
| Phase 4 | Completed | Hospital Central Dr. Luis Ortega | 40 | 2012-03 → 2012-09 | |
| Phase 2 | Completed | APR Applied Pharma Research s.a. | 17 | 2007-06 → 2007-08 | |
| Phase 3 | Completed | Behar, Caren, M.D. | 67 | 2009-10 → 2011-06 | |
| Phase 1 | Completed | X-pert Med GmbH | 82 | 2009-10 → 2010-01 | |
| Phase 4 | Completed | Luis Fernando Simoneti | 50 | 2015-06 → 2017-03 | |
| Phase 4 | Completed | Akdeniz University | 100 | 2015-02 → 2015-06 | |
| Phase 1 | Completed | Dompé Farmaceutici S.p.A | 30 | 2014-11-26 → 2015-04-22 | |
| Phase 3 | Completed | Sanofi | 52 | 2009-08 → 2010-05 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
7 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 |
|---|---|---|
| Dec 2, 2009 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.