DOCETAXEL | N201525 | SANDOZ
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2/3 | Active | NRG Oncology | 612 | 2017-04-05 → 2030-10-31 | |
| Phase 3 | Active | Novartis Pharmaceuticals | 95 | 2022-06-15 → 2026-10-03 | |
| Phase 3 | Active | UNICANCER | 1,173 | 2013-11-13 → 2032-12 | |
| Phase 3 | Active | National Cancer Institute (NCI) | 184 | 2021-06-28 → 2030-08-15 | |
| Phase 1 | Active | H. Lee Moffitt Cancer Center and Research Institute | 21 | 2019-02-01 → 2027-03 | |
| Phase 2 | Active | Lepu Biopharma Co., Ltd. | 238 | 2023-04-06 → 2026-12-30 | |
| Phase 1/2 | Active | Merck Sharp & Dohme LLC | 1,200 | 2016-11-17 → 2028-07-24 | |
| Phase 2 | Active | ECOG-ACRIN Cancer Research Group | 82 | 2019-03-12 → 2029-03-31 | |
| Phase 3 | Active | NRG Oncology | 300 | 2019-06-26 → 2036-11-07 | |
| Phase 3 | Active | Daiichi Sankyo | 605 | 2020-12-21 → 2027-02-15 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$10.05
Highest Price
$54.27
FSS NDCs
3
Big4 NDCs
0
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 43066-0001-01DOCETAXEL 10MG/ML INJ,CONC (20MG/2ML) | $10.05 | FSS | Baxter Healthcare Corporation | 08/14/2026 |
| 43066-0006-01DOCETAXEL 10MG/ML INJ,CONC (80MG/8ML) | $24.12 | FSS | Baxter Healthcare Corporation | 08/14/2026 |
| 43066-0010-01DOCETAXEL 10MG/ML INJ,CONC (160MG/16ML) | $54.27 | FSS | Baxter Healthcare Corporation | 08/14/2026 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
19 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 |
|---|---|---|
| Sep 22, 2023 | SUPPL -24 | View Letter (PDF) |
| Jan 14, 2021 | SUPPL -22 | View Letter (PDF) |
| Aug 12, 2020 | SUPPL -20 | View Letter (PDF) |
| Jan 7, 2020 | SUPPL -19 | View Letter (PDF) |
| Mar 29, 2019 | SUPPL -16 | View Letter (PDF) |
| Mar 29, 2019 | SUPPL -17 | View Letter (PDF) |
| Oct 25, 2016 | SUPPL -12 | View Letter (PDF) |
| Nov 5, 2014 | SUPPL -8 | View Letter (PDF) |
| Nov 5, 2014 | SUPPL -9 | View Letter (PDF) |
| Apr 24, 2014 | SUPPL -3 | View Letter (PDF) |
| Mar 19, 2012 | SUPPL -2 | View Letter (PDF) |
| Jul 6, 2011 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.