Aldoril 15, Aldoril 25, Aldoril D30

NDA 13402, held by Merck. Hydrochlorothiazide; Methyldopa.

As of Nov 14, 2026, NDA 13402 (Aldoril 15, Aldoril 25, Aldoril D30), held by Merck, was first approved by FDA on Dec 20, 1962, with 56 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1962
Review: Standard
Supplements approved: 56
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 57 submissions below

Date	Submission	Status	Documents
Dec 20, 1962	Original applicationNew combination · Standard review	Approved	None posted

Products

4 strengths and forms


Aldoril 1515MG;250MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued
Aldoril 2525MG;250MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued
Aldoril D3030MG;500MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued
Aldoril D5050MG;500MG · tablet;oral	Hydrochlorothiazide; Methyldopa	Discontinued

All 57 submissions, including labeling and manufacturing supplements


Dec 14, 2004	Supplement 85Labeling · Standard review	Approved	Letter
Apr 5, 2002	Supplement 84Manufacturing · Standard review	Approved	None posted
Jul 23, 1999	Supplement 81Labeling · Standard review	Approved	None posted
Jul 2, 1998	Supplement 82Manufacturing · Standard review	Approved	None posted
Aug 5, 1997	Supplement 80Labeling · Standard review	Approved	None posted
Nov 29, 1995	Supplement 79Manufacturing · Standard review	Approved	None posted
Dec 16, 1994	Supplement 77Labeling · Standard review	Approved	None posted
Sep 26, 1994	Supplement 78Manufacturing · Standard review	Approved	None posted
Mar 7, 1994	Supplement 76Labeling · Standard review	Approved	None posted
Mar 24, 1993	Supplement 75Labeling · Standard review	Approved	None posted
Dec 18, 1992	Supplement 72Labeling · Standard review	Approved	None posted
Sep 17, 1992	Supplement 74Labeling · Standard review	Approved	None posted
Sep 13, 1990	Supplement 73Labeling · Standard review	Approved	None posted
Apr 26, 1988	Supplement 70Manufacturing · Standard review	Approved	None posted
Apr 21, 1988	Supplement 71Labeling · Standard review	Approved	None posted
Aug 26, 1987	Supplement 69Labeling · Standard review	Approved	None posted
May 8, 1987	Supplement 56Labeling · Standard review	Approved	None posted
Jun 2, 1986	Supplement 68Labeling · Standard review	Approved	None posted
Oct 24, 1985	Supplement 67Labeling · Standard review	Approved	None posted
Jan 17, 1985	Supplement 66Manufacturing · Standard review	Approved	None posted
Nov 15, 1984	Supplement 65Labeling · Standard review	Approved	None posted
Aug 13, 1984	Supplement 64Labeling · Standard review	Approved	None posted
Apr 10, 1984	Supplement 62Manufacturing · Standard review	Approved	None posted
Apr 3, 1984	Supplement 63Labeling · Standard review	Approved	None posted
Jan 23, 1984	Supplement 61Manufacturing · Standard review	Approved	None posted
Dec 23, 1983	Supplement 60Manufacturing · Standard review	Approved	None posted
Mar 1, 1983	Supplement 59Manufacturing · Standard review	Approved	None posted
Sep 8, 1982	Supplement 57Labeling · Standard review	Approved	None posted
Apr 19, 1982	Supplement 58Manufacturing · Standard review	Approved	None posted
Oct 14, 1981	Supplement 55Labeling · Standard review	Approved	None posted
Aug 28, 1981	Supplement 42Manufacturing · Standard review	Approved	None posted
Jun 17, 1981	Supplement 53Manufacturing · Standard review	Approved	None posted
May 11, 1981	Supplement 52Labeling · Standard review	Approved	None posted
Apr 9, 1981	Supplement 51Manufacturing · Standard review	Approved	None posted
Mar 4, 1981	Supplement 50Manufacturing · Standard review	Approved	None posted
Jan 23, 1981	Supplement 49Manufacturing · Standard review	Approved	None posted
Nov 14, 1980	Supplement 48Manufacturing · Standard review	Approved	None posted
Jan 11, 1980	Supplement 47Labeling · Standard review	Approved	None posted
Jan 3, 1980	Supplement 46Manufacturing · Standard review	Approved	None posted
Oct 31, 1979	Supplement 32Labeling · Standard review	Approved	None posted
Oct 31, 1979	Supplement 44Labeling · Standard review	Approved	None posted
Oct 31, 1979	Supplement 45Labeling · Standard review	Approved	None posted
Mar 9, 1979	Supplement 43Manufacturing · Standard review	Approved	None posted
Nov 7, 1978	Supplement 41Manufacturing · Standard review	Approved	None posted
Aug 29, 1978	Supplement 40Manufacturing · Standard review	Approved	None posted
Jun 26, 1978	Supplement 37Labeling · Standard review	Approved	None posted
Jun 26, 1978	Supplement 39Manufacturing · Standard review	Approved	None posted
Feb 15, 1978	Supplement 33Manufacturing · Standard review	Approved	None posted
Oct 25, 1977	Supplement 38Manufacturing · Standard review	Approved	None posted
Sep 13, 1977	Supplement 34Labeling · Standard review	Approved	None posted
Sep 13, 1977	Supplement 35Manufacturing · Standard review	Approved	None posted
Sep 13, 1977	Supplement 36Manufacturing · Standard review	Approved	None posted
Nov 9, 1976	Supplement 31Manufacturing · Standard review	Approved	None posted
Aug 31, 1976	Supplement 30Labeling · Standard review	Approved	None posted
Mar 19, 1976	Supplement 29Manufacturing · Standard review	Approved	None posted
Jun 12, 1975	Supplement 28Manufacturing · Standard review	Approved	None posted
Dec 20, 1962	Original applicationNew combination · Standard review	Approved	None posted

Show all 57

Identifiers

Application: NDA 13402
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