LEVONORGESTREL | N021998 | FOUNDATION CONSUMER HEALTHCARE LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Active | M.D. Anderson Cancer Center | 69 | 2008-11-03 → 2027-11-30 | |
| Phase 2 | Active | M.D. Anderson Cancer Center | 102 | 2015-09-23 → 2026-09-30 | |
| Phase 1 | Active | Premier Research | 136 | 2020-03-03 → 2026-03-26 | |
| Phase 2 | Active | Queensland Centre for Gynaecological Cancer | 165 | 2012-12 → 2026-12 | |
| Phase 1 | Recruiting | AbbVie | 12 | 2019-07-30 → 2026-03-21 | |
| N/A | Completed | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | 6,360 | 1999-12 → 2002-12 | |
| Phase 1 | Completed | AstraZeneca | 38 | 2005-11 → 2006-08 | |
| Phase 3 | Completed | Mahidol University | 54 | 2007-04 → 2009-12 | |
| Phase 4 | Completed | Oregon Health and Science University | 120 | 2006-01 → 2006-05 | |
| Phase 2 | Completed | Teva Women's Health | 265 | 2010-11 → 2011-12 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
14 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 23, 2022 | SUPPL -5 | View Letter (PDF) |
| Feb 4, 2019 | SUPPL -6 | View Letter (PDF) |
| Aug 15, 2017 | SUPPL -4 | View Letter (PDF) |
| Jun 24, 2013 | SUPPL -3 | View Letter (PDF) |
| May 2, 2013 | SUPPL -2 | View Letter (PDF) |
| Jul 13, 2009 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.