NICOTINE | N020714 | PFIZER INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| N/A | Active | M.D. Anderson Cancer Center | 56 | 2024-02-15 → 2027-12-01 | |
| Phase 4 | Active | M.D. Anderson Cancer Center | 204 | 2015-12-14 → 2028-02-28 | |
| Phase 1 | Active | University of Pennsylvania | 13 | 2018-06-28 → 2026-11-22 | |
| N/A | Active | H. Lee Moffitt Cancer Center and Research Institute | 512 | 2021-12-15 → 2026-09-23 | |
| N/A | Active | M.D. Anderson Cancer Center | 135 | 2022-03-07 → 2026-10-17 | |
| Phase 1 | Active | JT International SA | 55 | 2026-01-08 → 2026-10 | |
| Phase 1/2 | Active | M.D. Anderson Cancer Center | 91 | 2007-06-28 → 2028-06-30 | |
| Early Phase 1 | Active | M.D. Anderson Cancer Center | 630 | 2017-06-16 → 2027-01-15 | |
| Phase 4 | Active | Johns Hopkins University | 30 | 2025-12-10 → 2027-06-30 | |
| N/A | Active | M.D. Anderson Cancer Center | 85 | 2016-08-05 → 2027-12-31 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
13 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 24, 2024 | SUPPL -19 | View Letter (PDF) |
| Sep 3, 2019 | SUPPL -18 | View Letter (PDF) |
| Jul 8, 2009 | SUPPL -16 | View Letter (PDF) |
| Jul 21, 2004 | SUPPL -12 | View Letter (PDF) |
| Nov 25, 2003 | SUPPL -11 | View Letter (PDF) |
| Sep 8, 2002 | SUPPL -10 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.