TEMOZOLOMIDE | N022277 | MERCK SHARP AND DOHME CORP
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 2 | Active | Pfizer | 128 | 2019-05-24 → 2025-10-18 | |
| Phase 1 | Active | University of Oklahoma | 27 | 2018-09-03 → 2026-11 | |
| Phase 2 | Active | Adam Burgoyne, MD, PhD | 23 | 2018-09-12 → 2026-06 | |
| Phase 3 | Active | Eastern Cooperative Oncology Group | 540 | 2009-11-17 → 2026-12-31 | |
| Phase 2 | Active | NRG Oncology | 120 | 2018-01-23 → 2026-07-15 | |
| Phase 1 | Active | Northwestern University | 18 | 2019-08-13 → 2027-06-01 | |
| Phase 2 | Active | Heinrich-Heine University, Duesseldorf | 136 | 2018-03-06 → 2027-05 | |
| Phase 1/2 | Active | Jonsson Comprehensive Cancer Center | 59 | 2019-03-06 → 2027-01-03 | |
| Phase 2 | Active | Cecilia Soderberg-Naucler | 220 | 2019-09-04 → 2027-09-16 | |
| Phase 2 | Active | National Cancer Institute (NCI) | 38 | 2018-11-06 → 2026-10-16 |
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 | $987.99 | FSS | Merck Sharp & Dohme LLC | 05/31/2030 |
| 00085-1381-01TEMODAR 100MG VIAL,INJ | $737.47 | Big4 | 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.