Neostigmine Methylsulfate

ANDA 209182, held by Am Regent. Neostigmine Methylsulfate.

As of Nov 15, 2026, ANDA 209182 (Neostigmine Methylsulfate), held by Am Regent, was first approved by FDA on May 4, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: May 4, 2018
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
May 4, 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 2 submissions, including labeling and manufacturing supplements


Nov 12, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 4, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209182
Drugs@FDA: Overview at FDA
Company: Am Regent

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