Neostigmine Methylsulfate

ANDA 213244, held by Eugia Pharma. Neostigmine Methylsulfate.

As of Nov 15, 2026, ANDA 213244 (Neostigmine Methylsulfate), held by Eugia Pharma, was first approved by FDA on Nov 2, 2023, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 2, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Neostigmine methylsulfate injection is a cholinesterase inhibitor indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Neostigmine methylsulfate injection, a cholinesterase inhibitor, is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents (NMBAs) after surgery.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 2, 2023	Original application	Approved	None posted

Products

4 strengths and forms


Neostigmine Methylsulfate5MG/10ML (0.5MG/ML) · solution;intravenous	Neostigmine Methylsulfate	Discontinued
Neostigmine Methylsulfate10MG/10ML (1MG/ML) · solution;intravenous	Neostigmine Methylsulfate	Discontinued
Neostigmine Methylsulfate5MG/10ML(0.5MG/ML) · injectable;injection	Neostigmine Methylsulfate	Rx
Neostigmine Methylsulfate10MG/10ML(1MG/ML) · injectable;injection	Neostigmine Methylsulfate	Rx

All 2 submissions, including labeling and manufacturing supplements


Oct 25, 2024	Supplement 2Labeling · Standard review	Approved	None posted
Nov 2, 2023	Original application	Approved	None posted

Identifiers

Application: ANDA 213244
Drugs@FDA: Overview at FDA
Company: Eugia Pharma

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters