GEMCITABINE HYDROCHLORIDE | N209604 | ACCORD HEALTHCARE INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Active | National Cancer Institute (NCI) | 55 | 2009-03-31 → 2027-03-06 | |
| Phase 3 | Active | Merck Sharp & Dohme LLC | 520 | 2020-05-19 → 2031-11-01 | |
| Phase 3 | Active | Sichuan Baili Pharmaceutical Co., Ltd. | 418 | 2024-06-21 → 2027-12 | |
| Phase 2 | Active | Queen Mary University of London | 170 | 2020-04-30 → 2029-02-28 | |
| Phase 1 | Active | AstraZeneca | 175 | 2018-12-27 → 2026-07-01 | |
| Phase 1 | Active | Regeneron Pharmaceuticals | 146 | 2017-06-21 → 2027-09-30 | |
| Phase 2 | Active | St. Jude Children's Research Hospital | 660 | 2013-06-23 → 2031-10-13 | |
| Phase 2/3 | Active | ECOG-ACRIN Cancer Research Group | 186 | 2021-02-24 → 2029-06-30 | |
| Phase 1 | Active | Hoffmann-La Roche | 50 | 2025-04-28 → 2027-03-22 | |
| Phase 3 | Active | Alliance for Clinical Trials in Oncology | 37 | 2024-12-11 → 2030-04-30 |
Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.
Lowest Price
$1.37
Highest Price
$28.14
FSS NDCs
7
Big4 NDCs
3
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 68001-0342-34GEMCITABINE 100MG/ML INJ,SOLN | $2.78 | Big4 | Amerisource Health Services LLC dba American Health Packaging | 09/14/2028 |
| 68001-0342-34GEMCITABINE 100MG/ML INJ,SOLN | $4.02 | FSS | Amerisource Health Services LLC dba American Health Packaging | 09/14/2028 |
| 68001-0348-36GEMCITABINE 100MG/ML INJ,SOLN | $7.39 | Big4 | Amerisource Health Services LLC dba American Health Packaging | 09/14/2028 |
| 68001-0348-36GEMCITABINE 100MG/ML INJ,SOLN | $14.07 | FSS | Amerisource Health Services LLC dba American Health Packaging | 09/14/2028 |
| 68001-0359-37GEMCITABINE 100MG/ML INJ,SOLN | $16.88 | Big4 | Amerisource Health Services LLC dba American Health Packaging | 09/14/2028 |
| 68001-0359-37GEMCITABINE 100MG/ML INJ,SOLN | $28.14 | FSS | Amerisource Health Services LLC dba American Health Packaging | 09/14/2028 |
Showing 6 of 10 NDCs.
Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.
16 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 26, 2024 | SUPPL -11 | View Letter (PDF) |
| Jun 26, 2019 | SUPPL -4 | View Letter (PDF) |
| Dec 21, 2018 | SUPPL -2 | View Letter (PDF) |
| Aug 3, 2018 | SUPPL -3 | View Letter (PDF) |
| Aug 7, 2017 | ORIG -1 | View Letter (PDF) |
Source: Drugs@FDA application documents.
No patent or exclusivity listings for this strength.