Regonol

NDA 17398, held by Sandoz. Pyridostigmine Bromide.

As of Nov 13, 2026, NDA 17398 (Regonol), held by Sandoz, was first approved by FDA on Aug 14, 1973, with 18 approved supplements and 0 published complete response letters.

First approved: Aug 14, 1973
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE REGONOL (pyridostigmine bromide injection, USP) is indicated as a reversal agent or antagonist to the neuromuscular blocking effects of nondepolarizing muscle relaxants.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Aug 14, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Regonol5MG/ML · injectable;injection	Pyridostigmine Bromide	Rx

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 5, 2021	Supplement 25Labeling · Standard review	Approved	Letter
May 18, 2016	Supplement 21Manufacturing · Standard review	Approved	None posted
Jul 22, 2013	Supplement 18Manufacturing · Standard review	Approved	None posted
Sep 21, 2004	Supplement 15Manufacturing · Standard review	Approved	Label Letter
Oct 17, 2003	Supplement 14Manufacturing · Standard review	Approved	Letter
Jul 12, 1999	Supplement 13Labeling · Standard review	Approved	None posted
Mar 15, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Mar 5, 1999	Supplement 5Labeling	Approved	None posted
Mar 4, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 28, 1994	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 6, 1992	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 5, 1990	Supplement 8Manufacturing · Standard review	Approved	None posted
Mar 30, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 10, 1987	Supplement 6Manufacturing · Standard review	Approved	None posted
May 18, 1982	Supplement 4Labeling	Approved	None posted
May 18, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 13, 1980	Supplement 2Labeling	Approved	None posted
Nov 13, 1980	Supplement 1Manufacturing · Standard review	Approved	None posted
Aug 14, 1973	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17398
Drugs@FDA: Overview at FDA
Company: Sandoz

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