Neostigmine Methylsulfate

ANDA 209933, held by Amphastar Pharms Inc. Neostigmine Methylsulfate.

As of Nov 15, 2026, ANDA 209933 (Neostigmine Methylsulfate), held by Amphastar Pharms Inc, was first approved by FDA on Sep 25, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Sep 25, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Neostigmine Methylsulfate Injection, USP, is a cholinesterase inhibitor indicated for the reversal of the effects of nondepolarizing neuromuscular blocking agents after surgery. Neostigmine Methylsulfate Injection, USP, 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 3 submissions below

Date	Submission	Status	Documents
Sep 25, 2017	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Oct 24, 2025	Supplement 2Labeling · Standard review	Approved	None posted
May 19, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Sep 25, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 209933
Drugs@FDA: Overview at FDA
Company: Amphastar Pharmaceuticals

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