Treats advanced ovarian cancer. Sold as Gemzar, Gemcitabine Hydrochloride, Infugem, Inlexzo, Avgemsi. Every FDA application for this active ingredient: 6 branded and 28 generic.
As of Nov 15, 2026, FDA lists 34 applications for Gemcitabine Hydrochloride (sold as Gemzar, Gemcitabine Hydrochloride, Infugem and others), first approved May 15, 1996, with 5 new uses approved and 2 published complete response letters.
| Inlexzo | Part D | $4.2M | New | 29 |
| Gemcitabine HCL (J9201) | Part B | $1.9M | -1% | 13,579 |
| Gemcitabine HCl | Part D | $526K | -1% | 1,108 |
| Gemcitabine HCL (J9196) | Part B | $317K | -74% | 1,274 |
| AVGEMSI | Part B | $0K | New | 0 |
| May 15, 1996 | GemzarNDA 20509 · New molecular entity | Lilly | 33 | Discontinued |
| Nov 15, 2010 | Gemcitabine HydrochlorideANDA 79183 | Hospira Inc | 5 | Marketed |
| Jan 25, 2011 | Gemcitabine HydrochlorideANDA 77983 | Teva Pharms | 4 | Discontinued |
| May 17, 2011 | Gemcitabine HydrochlorideANDA 90242 | Fresenius Kabi USA | 2 | Marketed |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 78433 | Sun Pharm | 2 | Marketed |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 91365 | Dr Reddys Labs Ltd | 6 | Marketed |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 78339 | Hospira | 7 | Marketed |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 91594 | Accord Hlthcare | 8 | Discontinued |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 78759 | Teyro Labs | 7 | Marketed |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 79160 | Actavis Totowa | 8 | Discontinued |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 90799 | Fresenius Kabi USA | 4 | Marketed |
| Jul 25, 2011 | Gemcitabine HydrochlorideANDA 200145 | Pharmobedient | 8 | Discontinued |
| Aug 4, 2011 | Gemcitabine HydrochlorideNDA 200795 · New dosage form | Hospira Inc | 9 | Marketed |
| Sep 10, 2012 | Gemcitabine HydrochlorideANDA 90663 | Hameln Rds GmbH | 0 | Discontinued |
| Sep 11, 2012 | Gemcitabine HydrochlorideANDA 202063 | Emcure Pharms Ltd | 6 | Discontinued |
| May 7, 2013 | Gemcitabine HydrochlorideANDA 91597 | Sagent Pharms | 0 | Discontinued |
| May 7, 2013 | Gemcitabine HydrochlorideANDA 202031 | Am Regent | 0 | Discontinued |
| May 7, 2013 | Gemcitabine HydrochlorideANDA 202485 | Jiangsu Hansoh Pharm | 5 | Marketed |
| May 7, 2013 | Gemcitabine HydrochlorideANDA 202997 | Dr Reddys Labs Ltd | 1 | Marketed |
| Jan 5, 2016 | Gemcitabine HydrochlorideANDA 204520 | Gland | 4 | Marketed |
| Apr 11, 2016 | Gemcitabine HydrochlorideANDA 204549 | Actavis Inc | 3 | Discontinued |
| May 23, 2017 | Gemcitabine HydrochlorideANDA 206776 | Apotex | 4 | Discontinued |
| Aug 3, 2017 | Gemcitabine HydrochlorideNDA 209604 · New formulation or manufacturer | Accord Hlthcare | 4 | Discontinued |
| Dec 6, 2017 | Gemcitabine HydrochlorideANDA 205242 | Mylan Labs Ltd | 3 | Marketed |
| Jul 16, 2018 | InfugemNDA 208313 · New dosage form | Sun Pharm | 2 | Discontinued |
| Jul 20, 2018 | Gemcitabine HydrochlorideANDA 209077 | Sagent Pharms Inc | 2 | Marketed |
| Feb 14, 2019 | Gemcitabine HydrochlorideANDA 210383 | Ingenus Pharms LLC | 2 | Discontinued |
| Feb 22, 2019 | Gemcitabine HydrochlorideANDA 207575 | Adaptis | 2 | Marketed |
| Oct 4, 2019 | Gemcitabine HydrochlorideANDA 210991 | Adaptis | 1 | Marketed |
| Dec 11, 2020 | Gemcitabine HydrochlorideANDA 212129 | Meitheal | 1 | Marketed |
| Jun 25, 2021 | Gemcitabine HydrochlorideANDA 206617 | Hikma Intl Pharms | 1 | Discontinued |
| Mar 7, 2023 | Gemcitabine HydrochlorideANDA 213175 | Hikma | 0 | Marketed |
| Jun 27, 2025 | AvgemsiNDA 219920 · New formulation or manufacturer | Avyxa Holdings | 1 | Marketed |
| Sep 9, 2025 | InlexzoNDA 219683 · New dosage form | Janssen Biotech | 0 | Marketed |
| May 23, 2017 | INFUGEM (gemcitabine injection)Facility Inspections | Approved |
| Nov 24, 2015 | Gemcitabine HydrochlorideFacility Inspections, Manufacturing Process, Human Factor Study | Approved |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Lilly
Fresenius Kabi USA
Accord Hlthcare
Apotex
Mylan Labs Ltd
Hikma