LORATADINE | N021952 | BAYER HEALTHCARE LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Early Phase 1 | Recruiting | Rutgers, The State University of New Jersey | 70 | 2022-04-18 → 2027-06-30 | |
| Phase 3 | Completed | Organon and Co | 1,214 | 2001-04 → 2001-07 | |
| Phase 2 | Completed | Thai Traditional Medical Knowledge Fund | 80 | 2015-10 → 2017-10 | |
| Phase 1 | Completed | Zalicus | 20 | 2008-07 → 2008-09 | |
| Phase 4 | Completed | Universidade do Sul de Santa Catarina | 73 | 2013-08 → 2014-08 | |
| N/A | Completed | Ranbaxy Laboratories Limited | 80 | 2006-06 → 2006-09 | |
| Phase 3 | Completed | Organon and Co | 69 | 2012-07-04 → 2012-10-10 | |
| Phase 1 | Completed | Bayer | 29 | 2018-04-24 → 2018-08-30 | |
| Phase 3 | Completed | ALK-Abelló A/S | 439 | 2007-11 → 2009-09 | |
| Phase 4 | Completed | Merck Sharp & Dohme LLC | 100 | 2003-09 → 2006-11 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
10 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 |
|---|---|---|
| Apr 27, 2026 | SUPPL -24 | View Letter (PDF) |
| Jun 1, 2023 | SUPPL -22 | View Letter (PDF) |
| Dec 31, 2018 | SUPPL -18 | View Letter (PDF) |
| Jul 23, 2018 | SUPPL -17 | View Letter (PDF) |
| Jun 27, 2018 | SUPPL -16 | View Letter (PDF) |
| Jun 5, 2018 | SUPPL -15 | View Letter (PDF) |
| Apr 23, 2018 | SUPPL -14 | View Letter (PDF) |
| Dec 10, 2015 | SUPPL -12 | View Letter (PDF) |
| Apr 10, 2009 | SUPPL -3 | View Letter (PDF) |
| Jun 19, 2008 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.