Guanidine Hydrochloride

NDA 1546, held by Merck Sharp Dohme. Guanidine Hydrochloride.

As of Nov 13, 2026, NDA 1546 (Guanidine Hydrochloride), held by Merck Sharp Dohme, was first approved by FDA on Oct 2, 1939, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 2, 1939
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 2, 1939	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Guanidine Hydrochloride125MG · tablet;oral	Guanidine Hydrochloride	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Aug 3, 2015	Supplement 22Manufacturing	Approved	None posted
Sep 30, 2014	Supplement 21Manufacturing	Approved	None posted
Apr 24, 2002	Supplement 11Labeling	Approved	Letter
Jun 16, 2000	Supplement 15Manufacturing	Approved	None posted
Feb 14, 2000	Supplement 14Manufacturing	Approved	None posted
Dec 23, 1998	Supplement 13Manufacturing	Approved	None posted
Oct 28, 1992	Supplement 12Manufacturing	Approved	None posted
Dec 11, 1986	Supplement 10Manufacturing	Approved	None posted
Dec 5, 1984	Supplement 9Manufacturing	Approved	None posted
Aug 2, 1983	Supplement 8Manufacturing	Approved	None posted
Jun 16, 1980	Supplement 7Manufacturing	Approved	None posted
Feb 16, 1978	Supplement 6Manufacturing	Approved	None posted
Sep 23, 1976	Supplement 5Labeling	Approved	None posted
Jan 29, 1975	Supplement 4Manufacturing	Approved	None posted
Oct 2, 1939	Original application	Approved	None posted

Identifiers

Application: NDA 1546
Drugs@FDA: Overview at FDA
Company: Merck Sharp & Dohme

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