For severe. Sold as Levophed, Norepinephrine Bitartrate In 5% Dextrose, Norepinephrine Bitartrate In 0.9% Sodium Chloride. Every FDA application for this active ingredient: 4 branded and 22 generic.
As of Nov 14, 2026, FDA lists 26 applications for Norepinephrine Bitartrate (sold as Levophed, Norepinephrine Bitartrate In 5% Dextrose, Norepinephrine Bitartrate In 0.9% Sodium Chloride), first approved Jul 13, 1950, with 0 new uses approved and 1 published complete response letter.
| Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS)Spine Surgery, Intraoperative Hypotension · Mayo Clinic | Phase 4 | Not yet recruiting | Sep 1, 2026 |
| Early Norepinephrine in Trauma Patients With Hemorrhagic ShockTrauma, Multiple · Visarat Palitnonkiat | Phase 1 / Phase 2 | Enrolling by invitation | May 18, 2025 |
| Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex DifferencesVasoconstriction, Vasodilation · University of Alberta | Phase 4 | Recruiting | Aug 18, 2023 |
| Early Administration of Norepinephrine in SepsisSepsis, Severe · Tunis University | Phase 4 | Recruiting | May 1, 2023 |
| Letter | Product | Now |
|---|---|---|
| Jun 14, 2021 | Norepinephrine Bitartrate in Sodium ChlorideFacility Inspections | 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
Hikma
Baxter Hlthcare Corp
Mylan Labs Ltd
Sandoz
Fresenius Kabi USA
Zydus Pharms
Nephron