Neostigmine Methylsulfate

ANDA 209135, held by Dr Reddys. Neostigmine Methylsulfate.

As of Nov 15, 2026, ANDA 209135 (Neostigmine Methylsulfate), held by Dr Reddys, was first approved by FDA on Jul 10, 2018, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 10, 2018
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.

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
Jul 10, 2018	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 2 submissions, including labeling and manufacturing supplements


Jun 8, 2022	Supplement 2Labeling · Standard review	Approved	None posted
Jul 10, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209135
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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