Neostigmine Methylsulfate

ANDA 212968, held by Gland. Neostigmine Methylsulfate.

As of Nov 15, 2026, ANDA 212968 (Neostigmine Methylsulfate), held by Gland, was first approved by FDA on Oct 16, 2019, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2019
Review: Standard
Supplements approved: 2
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 3 submissions below

Date	Submission	Status	Documents
Oct 16, 2019	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


Sep 14, 2026	Supplement 2Labeling · Standard review	Approved	None posted
May 4, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Oct 16, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 212968
Drugs@FDA: Overview at FDA
Company: Gland 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