TEMOZOLOMIDE | N022277 | MERCK SHARP AND DOHME CORP
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Active | Valent Technologies, LLC | 20 | 2021-10-25 → 2026-12 | |
| Phase 2 | Active | Mayo Clinic | 52 | 2018-01-15 → 2028-06-06 | |
| Phase 1 | Active | University of Oklahoma | 27 | 2018-09-03 → 2026-12-31 | |
| Phase 2 | Active | L. Nicolas Gonzalez Castro, MD, PhD | 52 | 2022-10-21 → 2027-03-01 | |
| Phase 1 | Active | National Cancer Institute (NCI) | 23 | 2019-05-01 → 2027-09-18 | |
| Phase 1 | Active | Novartis Pharmaceuticals | 63 | 2022-05-10 → 2027-05-24 | |
| Phase 2 | Active | National Cancer Institute (NCI) | 23 | 2019-08-19 → 2026-11-12 | |
| Phase 1 | Active | Northwestern University | 86 | 2022-08-08 → 2029-01-03 | |
| Early Phase 1 | Active | Memorial Sloan Kettering Cancer Center | 48 | 2017-06-12 → 2027-06 | |
| Phase 2 | Active | Annick Desjardins, MD | 43 | 2020-08-26 → 2027-03-31 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$737.47
Highest Price
$987.99
FSS NDCs
1
Big4 NDCs
1
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 00085-1381-01TEMODAR 100MG VIAL,INJ | $737.47 | Big4 | Merck Sharp & Dohme LLC | 05/31/2030 |
| 00085-1381-01TEMODAR 100MG VIAL,INJ | $987.99 | FSS | Merck Sharp & Dohme LLC | 05/31/2030 |
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
15 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 15, 2023 | SUPPL -19 | View Letter (PDF) |
| Sep 15, 2023 | SUPPL -18 | View Letter (PDF) |
| Sep 15, 2023 | SUPPL -17 | View Letter (PDF) |
| Nov 25, 2020 | SUPPL -14 | View Letter (PDF) |
| Nov 26, 2019 | SUPPL -13 | View Letter (PDF) |
| Oct 12, 2017 | SUPPL -12 | View Letter (PDF) |
| Mar 2, 2017 | SUPPL -10 | View Letter (PDF) |
| Feb 16, 2016 | SUPPL -11 | View Letter (PDF) |
| Sep 22, 2015 | SUPPL -9 | View Letter (PDF) |
| Apr 3, 2015 | SUPPL -8 | View Letter (PDF) |
| May 6, 2014 | SUPPL -7 | View Letter (PDF) |
| Jun 9, 2011 | SUPPL -5 | View Letter (PDF) |
| Apr 29, 2010 | SUPPL -1 | View Letter (PDF) |
| Mar 5, 2009 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.