Neostigmine Methylsulfate

ANDA 210051, held by Amneal. Neostigmine Methylsulfate.

As of Nov 15, 2026, ANDA 210051 (Neostigmine Methylsulfate), held by Amneal, was first approved by FDA on Jun 15, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 15, 2018
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.

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
Jun 15, 2018	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Nov 16, 2022	Supplement 5Labeling · Standard review	Approved	None posted
May 5, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Jun 15, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 210051
Drugs@FDA: Overview at FDA
Company: Amneal 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