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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 212627

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NDA 212627 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, Ph Health, Regcon Holdings, Sagent Pharms Inc, and Umedica, 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 212627

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

Medical Subject Heading (MeSH) Categories for 212627

Cholinesterase Inhibitors
Parasympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	5MG/10ML (0.5MG/ML)
Approval Date:	Nov 3, 2022	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	10MG/10ML (1MG/ML)
Approval Date:	Nov 3, 2022	TE:	AP	RLD:	No

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