Last Updated: June 24, 2026

Details for New Drug Application (NDA): 216206

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NDA 216206 describes NEOSTIGMINE METHYLSULFATE, which is a drug marketed by Am Regent, Amneal, Amphastar Pharms Inc, Amring Pharms, Avet Lifesciences, Be Pharms, Caplin, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Meitheal, Nivagen Pharms Inc, Ph Health, Regcon Holdings, and Sagent Pharms Inc, and is included in nineteen NDAs. It is available from twenty-three suppliers. Additional details are available on the NEOSTIGMINE METHYLSULFATE profile page.

The generic ingredient in NEOSTIGMINE METHYLSULFATE is neostigmine methylsulfate. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the neostigmine methylsulfate profile page.

Summary for 216206

Tradename:	NEOSTIGMINE METHYLSULFATE
Applicant:	Hikma
Ingredient:	neostigmine methylsulfate
Patents:	0

Medical Subject Heading (MeSH) Categories for 216206

Cholinesterase Inhibitors
Parasympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	3MG/3ML (1MG/ML)
Approval Date:	Jul 13, 2022	TE:		RLD:	No

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