Neostigmine Methylsulfate

Sold as Neostigmine Methylsulfate, Bloxiverz. Every FDA application for this active ingredient: 2 branded and 18 generic.

As of Nov 15, 2026, FDA lists 20 applications for Neostigmine Methylsulfate (sold as Neostigmine Methylsulfate, Bloxiverz), first approved May 31, 2013, with 0 new uses approved and 0 published complete response letters.

First approved: May 31, 2013
Applications: 20
New uses approved: 0
Complete response letters: 0

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of Myasthenia GravisLuitpold Pharmaceuticals, Inc. · designated Feb 17, 2012

Shortages

FDA's drug shortage list, as of Nov 13, 2026

Shortage	Status	First posted	Updated
Neostigmine Methylsulfate Injection	To Be Discontinued	Jan 12, 2026	Jan 12, 2026

Clinical Trials

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


Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPHPostdural Puncture Headache (PDPH) · Assiut University	Phase 2 / Phase 3	Recruiting	Nov 4, 2026
Unilateral Spinal vs General Anaesthesia in Low EF Patients: A Hemodynamic ComparisonHemodynamic (MAP) Stability · Sargodha Medical College	—	Enrolling by invitation	Aug 7, 2026
Study on Neostigmine Acupoint Injection at Zusanli(ST36) for Treating Mechanical Ventilation-Associated Gastrointestinal DysfunctionGastrointestinal Dysfunction · Southeast University, China	Not applicable	Not yet recruiting	Jul 9, 2026
Postoperative GI Dysfunction and Nutrition in Malnourished Cancer Surgery PatientsGastrointestinal Dysfunction, Malnutrition · Arma Ltd.	—	Not yet recruiting	Jun 3, 2026
Antagonism of Neostigmine in Continuous Infusion of MivacuriumNeuromuscular Blocking Agents · Beijing Tongren Hospital	Not applicable	Not yet recruiting	Apr 13, 2026
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary FunctionResidual Neuromuscular Block · Shanghai Pulmonary Hospital, Shanghai, China	Not applicable	Recruiting	Dec 30, 2025
Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal SurgeryPostoperative Gastrointestinal Dysfunction (POGD), Postoperative Ileus · Xijing Hospital	Phase 3	Not yet recruiting	Dec 9, 2025
Emergence AgitationEmergence Agitation, Nasal Surgery · Ain Shams University	Not applicable	Active, not recruiting	Nov 28, 2025

Applications

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


May 31, 2013	BloxiverzNDA 204078 · New formulation or manufacturer	Exela Pharma	8	Discontinued
Jan 8, 2015	Neostigmine MethylsulfateNDA 203629 · New dosage form	Fresenius Kabi USA	2	Marketed
Dec 28, 2015	Neostigmine MethylsulfateANDA 207042	Hikma	1	Marketed
Apr 26, 2017	Neostigmine MethylsulfateANDA 208405	Ph Health	1	Marketed
Sep 25, 2017	Neostigmine MethylsulfateANDA 209933	Amphastar Pharms Inc	2	Marketed
May 4, 2018	Neostigmine MethylsulfateANDA 209182	Am Regent	1	Discontinued
Jun 15, 2018	Neostigmine MethylsulfateANDA 210051	Amneal	2	Discontinued
Jul 10, 2018	Neostigmine MethylsulfateANDA 209135	Dr Reddys	1	Marketed
Aug 22, 2018	Neostigmine MethylsulfateANDA 210989	J Molner	0	Marketed
May 13, 2019	Neostigmine MethylsulfateANDA 212512	Be Pharms	1	Marketed
Oct 16, 2019	Neostigmine MethylsulfateANDA 212968	Gland	2	Marketed
Apr 5, 2021	Neostigmine MethylsulfateANDA 212804	Meitheal	0	Marketed
Apr 20, 2021	Neostigmine MethylsulfateANDA 213074	Caplin	0	Marketed
Oct 1, 2021	Neostigmine MethylsulfateANDA 210652	Regcon Holdings	0	Marketed
Jul 6, 2022	Neostigmine MethylsulfateANDA 216291	Dr Reddys	0	Marketed
Jul 13, 2022	Neostigmine MethylsulfateANDA 216206	Hikma	0	Discontinued
Nov 3, 2022	Neostigmine MethylsulfateANDA 212627	Nivagen	0	Marketed
Nov 25, 2022	Neostigmine MethylsulfateANDA 208230	Avet Lifesciences	0	Marketed
Feb 17, 2023	Neostigmine MethylsulfateANDA 216542	Sagent Pharms Inc	0	Marketed
Nov 2, 2023	Neostigmine MethylsulfateANDA 213244	Eugia Pharma	1	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