GEMCITABINE HYDROCHLORIDE | N209604 | ACCORD HEALTHCARE INC
| Trial | Phase | Status | Sponsor | Enrollment | Dates |
|---|---|---|---|---|---|
| Phase 1 | Active | Regeneron Pharmaceuticals | 146 | 2017-06-21 → 2027-09-30 | |
| Phase 2 | Active | ECOG-ACRIN Cancer Research Group | 176 | 2020-08-26 → 2026-12-31 | |
| Phase 3 | Active | University of Birmingham | 450 | 2017-08-24 → 2027-12 | |
| Phase 3 | Active | Astellas Pharma Global Development, Inc. | 886 | 2020-03-30 → 2028-03-01 | |
| N/A | Active | Memorial Sloan Kettering Cancer Center | 110 | 2016-10 → 2026-10 | |
| Phase 3 | Active | Merck Sharp & Dohme LLC | 520 | 2020-05-19 → 2031-11-01 | |
| Phase 2 | Active | AGO Research GmbH | 136 | 2021-10-13 → 2026-12 | |
| Phase 2/3 | Active | Fudan University | 503 | 2016-01 → 2027-12 | |
| Phase 2 | Active | University of Maryland, Baltimore | 15 | 2019-12-12 → 2026-12-31 | |
| Phase 2 | Active | University Health Network, Toronto | 57 | 2014-11 → 2027-09 |
Source: ClinicalTrials.gov. Trials matched by ingredient name.
Lowest Price
$1.37
Highest Price
$28.14
FSS NDCs
7
Big4 NDCs
3
| Description | Price | Type | Vendor | Contract End |
|---|---|---|---|---|
| 16729-0391-30GEMCITABINE HCL 200MG/VIL INJ | $2.01 | FSS | Accord Healthcare Inc. | 07/31/2026 |
| 16729-0419-03GEMCITABINE HCL 1GM/VIL INJ | $3.64 | FSS | Accord Healthcare Inc. | 07/31/2026 |
| 68001-0348-36GEMCITABINE 100MG/ML INJ,SOLN | $14.07 | 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 |
| 68001-0342-34GEMCITABINE 100MG/ML INJ,SOLN | $4.02 | FSS | Amerisource Health Services LLC dba American Health Packaging | 09/14/2028 |
| 68001-0342-34GEMCITABINE 100MG/ML INJ,SOLN | $2.78 | Big4 | 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.