Humorsol

NDA 11860, held by Merck. Demecarium Bromide.

As of Nov 14, 2026, NDA 11860 (Humorsol), held by Merck, was first approved by FDA on Aug 5, 1959, with 22 approved supplements and 0 published complete response letters.

First approved: Aug 5, 1959
Review: Standard
Supplements approved: 22
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Aug 5, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Humorsol0.25% · solution/drops;ophthalmic	Demecarium Bromide	Discontinued
Humorsol0.125% · solution/drops;ophthalmic	Demecarium Bromide	Discontinued

All 23 submissions, including labeling and manufacturing supplements


May 29, 1998	Supplement 30Manufacturing · Standard review	Approved	None posted
Apr 15, 1998	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 4, 1997	Supplement 29Manufacturing · Standard review	Approved	None posted
Feb 20, 1997	Supplement 28Manufacturing · Standard review	Approved	None posted
Jan 30, 1997	Supplement 27Manufacturing · Standard review	Approved	None posted
Apr 16, 1996	Supplement 26Manufacturing · Standard review	Approved	None posted
Apr 25, 1995	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 22, 1993	Supplement 24Labeling · Standard review	Approved	None posted
Apr 23, 1991	Supplement 23Labeling · Standard review	Approved	None posted
Jan 13, 1988	Supplement 22Manufacturing · Standard review	Approved	None posted
May 6, 1987	Supplement 14Labeling · Standard review	Approved	None posted
Feb 25, 1986	Supplement 20Manufacturing · Standard review	Approved	None posted
Feb 12, 1986	Supplement 19Manufacturing · Standard review	Approved	None posted
Dec 6, 1984	Supplement 18Manufacturing · Standard review	Approved	None posted
Jun 14, 1984	Supplement 17Manufacturing · Standard review	Approved	None posted
Oct 27, 1981	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 13, 1981	Supplement 15Manufacturing · Standard review	Approved	None posted
Jul 15, 1981	Supplement 13Manufacturing · Standard review	Approved	None posted
Dec 21, 1979	Supplement 12Manufacturing · Standard review	Approved	None posted
Jul 5, 1978	Supplement 11Labeling · Standard review	Approved	None posted
Jun 22, 1978	Supplement 8Labeling · Standard review	Approved	None posted
Apr 21, 1976	Supplement 10Manufacturing · Standard review	Approved	None posted
Aug 5, 1959	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 11860
Drugs@FDA: Overview at FDA
Company: Merck & Co. (MSD)

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