Timolide 10-25

NDA 18061, held by Merck. Hydrochlorothiazide; Timolol Maleate.

As of Nov 13, 2026, NDA 18061 (Timolide 10-25), held by Merck, was first approved by FDA on Dec 11, 1981, with 29 approved supplements and 0 published complete response letters.

First approved: Dec 11, 1981
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below


Mar 13, 2009	Supplement 2Efficacy (new indication or use)	Approved	None posted
Feb 3, 1988	Supplement 4Efficacy (new indication or use)	Approved	None posted
Dec 11, 1981	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Timolide 10-2525MG;10MG · tablet;oral	Hydrochlorothiazide; Timolol Maleate	Discontinued

All 30 submissions, including labeling and manufacturing supplements


Mar 13, 2009	Supplement 2Efficacy (new indication or use)	Approved	None posted
Mar 4, 2003	Supplement 29Labeling · Standard review	Approved	Letter
Apr 5, 2002	Supplement 30Manufacturing · Standard review	Approved	None posted
Oct 13, 1998	Supplement 25Labeling · Standard review	Approved	None posted
May 15, 1998	Supplement 28Labeling · Standard review	Approved	None posted
May 4, 1998	Supplement 26Manufacturing · Standard review	Approved	None posted
Feb 13, 1998	Supplement 27Manufacturing · Standard review	Approved	None posted
Jul 9, 1997	Supplement 24Manufacturing · Standard review	Approved	None posted
Feb 9, 1994	Supplement 23Labeling · Standard review	Approved	None posted
Jan 22, 1993	Supplement 22Labeling · Standard review	Approved	None posted
Aug 12, 1991	Supplement 21Labeling	Approved	None posted
Apr 21, 1989	Supplement 20Manufacturing · Standard review	Approved	None posted
Aug 15, 1988	Supplement 15Manufacturing · Standard review	Approved	None posted
Feb 3, 1988	Supplement 19Labeling	Approved	None posted
Feb 3, 1988	Supplement 4Efficacy (new indication or use)	Approved	None posted
Aug 26, 1987	Supplement 16Labeling	Approved	None posted
Jun 1, 1987	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 8, 1987	Supplement 17Labeling	Approved	None posted
Aug 8, 1986	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 2, 1986	Supplement 13Labeling	Approved	None posted
Sep 6, 1985	Supplement 12Labeling	Approved	None posted
Oct 4, 1984	Supplement 11Labeling	Approved	None posted
Apr 18, 1984	Supplement 10Labeling	Approved	None posted
Dec 23, 1983	Supplement 8Manufacturing · Standard review	Approved	None posted
Aug 24, 1983	Supplement 9Labeling	Approved	None posted
Sep 20, 1982	Supplement 6Labeling	Approved	None posted
Sep 20, 1982	Supplement 5Labeling	Approved	None posted
May 7, 1982	Supplement 1Manufacturing · Standard review	Approved	None posted
Feb 24, 1982	Supplement 3Manufacturing · Standard review	Approved	None posted
Dec 11, 1981	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 18061
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