LANSOPRAZOLE | N021281 | TAKEDA PHARMACEUTICALS NORTH AMERICA INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Completed | Teva Pharmaceuticals USA | 50 | 2004-01 → 2004-01 | |
| Phase 1 | Completed | Takeda | 24 | 2005-01 → 2005-07 | |
| Phase 4 | Completed | Takeda | 506 | 2002-06 → 2008-09 | |
| Phase 4 | Completed | King Saud University | 1,920 | 2012-01 → 2015-12 | |
| Phase 4 | Completed | Takeda | 208 | 2016-03-20 → 2022-03-05 | |
| Phase 3 | Completed | Takeda | 621 | 2011-10 → 2013-04 | |
| Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 48 | 2008-12 → 2008-12 | |
| Phase 3 | Completed | HK inno.N Corporation | 284 | 2018-06-28 → 2019-12-31 | |
| Phase 4 | Completed | AstraZeneca | 750 | 2002-12 → 2004-01 | |
| Phase 2 | Completed | Sanford Health | 70 | 2010-08 → 2015-03 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
22 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 |
|---|---|---|
| Nov 12, 2009 | SUPPL -26 | View Letter (PDF) |
| Oct 29, 2008 | SUPPL -24 | View Letter (PDF) |
| Apr 23, 2008 | SUPPL -22 | View Letter (PDF) |
| Jul 5, 2007 | SUPPL -21 | View Letter (PDF) |
| Apr 13, 2006 | SUPPL -17 | View Letter (PDF) |
| Jun 23, 2004 | SUPPL -14 | View Letter (PDF) |
| Aug 15, 2003 | SUPPL -9 | View Letter (PDF) |
| Dec 3, 2002 | SUPPL -4 | View Letter (PDF) |
| Aug 30, 2002 | SUPPL -7 | View Letter (PDF) |
| May 3, 2002 | SUPPL -2 | View Letter (PDF) |
| May 3, 2001 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.