Sold as Ketalar. Every FDA application for this active ingredient: 1 branded and 12 generic.
As of Nov 15, 2026, FDA lists 13 applications for Ketamine Hydrochloride (sold as Ketalar), first approved Feb 19, 1970, with 1 new use approved and 0 published complete response letters.
| Exploring Ketamine's Effects on Depression and Anxiety in Adults With Low VisionDepression, Anxiety · Stanford University | Phase 2 | Not yet recruiting | Nov 12, 2026 |
| Effect of Ketamine on Optic Nerve Sheath Diameter During Procedural AnalgesiaProcedural Pain, Procedural Sedation and Analgesia · Ankara Etlik City Hospital | — | Recruiting | Nov 4, 2026 |
| Dexmedetomidine Versus Ketamine in TAP Block for Postoperative Analgesia After Total Abdominal HysterectomyPostoperative Pain, Total Abdominal Hysterectomy · Bangladesh Medical University | Phase 4 | Recruiting | Sep 29, 2026 |
| Two Intravenous Doses of Ketamine in Reducing the Oculocardiac Reflex in Adult Patients Undergoing Ophthalmic SurgeryKetamine, Oculocardiac Reflex · Cairo University | Not applicable | Recruiting | Jul 16, 2026 |
| Subanesthetic Ketamine Infusions for Depressive Symptoms in Intensive Care Unit PatientsCritical Illness, Depressive Symptoms · Hospital Italiano de Buenos Aires | Phase 2 | Recruiting | Jun 10, 2026 |
| Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)Borderline Personality Disorder (BPD), Treatment-Resistant Major Depressive Disorder · Joshua Rosenblat | Phase 2 | Recruiting | May 6, 2026 |
| Intranasal Dexmedetomidine or Esketamine for Negative Postoperative Behavioral Changes in ChildrenBehavior Problem · Nanjing Children's Hospital | Phase 4 | Not yet recruiting | May 6, 2026 |
| Optimal Timing of Ketamine Initiation for SCD PainSickle Cell Disease, Sickle Cell Crisis · Boston Children's Hospital | Phase 3 | Not yet recruiting | Mar 4, 2026 |
| Feb 19, 1970 | KetalarNDA 16812 · New molecular entity | Ph Health | 26 | Marketed |
| Mar 22, 1996 | Ketamine HydrochlorideANDA 74524 | Hikma | 7 | Marketed |
| Jun 27, 1996 | Ketamine HydrochlorideANDA 74549 | Hospira | 10 | Marketed |
| Dec 28, 2001 | Ketamine HydrochlorideANDA 76092 | Eugia Pharma | 8 | Marketed |
| Jan 13, 2023 | Ketamine HydrochlorideANDA 215808 | Fresenius Kabi USA | 0 | Marketed |
| Jan 24, 2023 | Ketamine HydrochlorideANDA 216809 | Gland | 1 | Marketed |
| Aug 7, 2025 | Ketamine HydrochlorideANDA 217858 | Caplin | 0 | Discontinued |
| Sep 17, 2025 | Ketamine HydrochlorideANDA 219684 | Baxter Hlthcare Corp | 0 | Marketed |
| Oct 28, 2026 | Ketamine HydrochlorideANDA 220602 | Neurorx | 0 | Marketed |
| — | Ketamine HclANDA 71949 | Quad Pharms | 0 | Discontinued |
| — | Ketamine HclANDA 71950 | Quad Pharms | 0 | Discontinued |
| — | Ketamine HclANDA 71951 | Quad Pharms | 0 | Discontinued |
| — | Ketamine HydrochlorideANDA 220380 | Amneal | 0 | Marketed |
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
Hikma
Eugia Pharma
Fresenius Kabi USA
Baxter Hlthcare Corp