Epinephrine Bitartrate

For hypotension associated with septic shock. Sold as Medihaler-Epi, Bronitin Mist, Epinephrine Bitartrate In 0.9% Sodium Chloride. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 3 applications for Epinephrine Bitartrate (sold as Medihaler-Epi, Bronitin Mist, Epinephrine Bitartrate In 0.9% Sodium Chloride), first approved Mar 9, 1956, with 0 new uses approved and 0 published complete response letters.

First approved: Mar 9, 1956
Applications: 3
New uses approved: 0
Complete response letters: 0

Clinical Trials

245 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Pectoral Nerve Block Versus Serratus Posterior Superior Intercostal Plane Block for Pain Control After MastectomyPostoperative Pain, Breast Cancer · Bursa City Hospital	Not applicable	Recruiting	Nov 10, 2026
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University HospitalCesarean Section · Assiut University	Phase 4	Active, not recruiting	Nov 6, 2026
Reducing Blood Loss During Myomectomy by Comparing Local Epinephrine and Uterine Artery Tourniquet During ProcedureLocal Epinephrine in Myomectomy · Pakistan Institute of Medical Sciences	Not applicable	Enrolling by invitation	Nov 5, 2026
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary MolarsPulpitis · Suez Canal University	Phase 3	Not yet recruiting	Nov 5, 2026
Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal DissectionGastric Neoplasms, Gastric Dysplasia · Unidade Local de Saúde do Alto Ave, EPE	Not applicable	Recruiting	Nov 5, 2026
Comparing Long-Acting Local Pain Relief Methods in PLIF SurgeryPosterior Lumbar Interbody Fusion (PLIF), Postoperative Analgesia After Disc Surgery · First Affiliated Hospital of Kunming Medical University	Not applicable	Not yet recruiting	Nov 5, 2026
Safety of Intraosseous Anaesthesia in Children With HaemophiliaHaemophilia A, Haemophilia B · Ankara Yildirim Beyazıt University	Not applicable	Not yet recruiting	Nov 4, 2026
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local AnesthesiaChronic Subdural Hematoma · National Institute of Neurology, Tunisia	Phase 4	Not yet recruiting	Nov 3, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Mar 9, 1956	Medihaler-EpiNDA 10374	3m	12	Discontinued
Nov 8, 1967	Primatene Mist, Bronitin MistNDA 16126 · New formulation or manufacturer	Wyeth Cons	21	Discontinued
Feb 28, 2025	Epinephrine Bitartrate In 0.9% Sodium ChlorideNDA 218475 · New formulation or manufacturer	Baxter Hlthcare Corp	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