LORATADINE | N021993 | BAYER HEALTHCARE LLC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 4 | Recruiting | Emory University | 94 | 2025-09-24 → 2027-12-31 | |
| N/A | Recruiting | Alexandria University | 88 | 2025-03-01 → 2027-07 | |
| Early Phase 1 | Recruiting | Rutgers, The State University of New Jersey | 70 | 2022-04-18 → 2027-06-30 | |
| Phase 2 | Recruiting | Val Adams | 98 | 2026-06-26 → 2027-07-31 | |
| Phase 3 | Completed | Organon and Co | 1,214 | 2001-04 → 2001-07 | |
| Phase 3 | Completed | Organon and Co | 907 | 1999-09 → 1999-11 | |
| N/A | Completed | University of Turin, Italy | 22 | 2002-01 → 2011-01 | |
| Phase 1 | Completed | Bayer | 52 | 2018-04-17 → 2018-07-20 | |
| Phase 1 | Completed | Xian-Janssen Pharmaceutical Ltd. | 28 | 2017-06-01 → 2017-07-08 | |
| Phase 4 | Completed | Universidade do Sul de Santa Catarina | 73 | 2013-08 → 2014-08 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
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 |
|---|---|---|
| May 26, 2023 | SUPPL -23 | View Letter (PDF) |
| Mar 1, 2019 | SUPPL -17 | View Letter (PDF) |
| Jul 25, 2018 | SUPPL -16 | View Letter (PDF) |
| Nov 27, 2015 | SUPPL -13 | View Letter (PDF) |
| Jul 24, 2014 | SUPPL -12 | View Letter (PDF) |
| Oct 23, 2008 | SUPPL -4 | View Letter (PDF) |
| Dec 14, 2006 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.