Diupres-250, Diupres-500

NDA 11635, held by Merck. Chlorothiazide; Reserpine.

As of Nov 13, 2026, NDA 11635 (Diupres-250, Diupres-500), held by Merck, was first approved by FDA on Dec 11, 1958, with 8 approved supplements and 0 published complete response letters.

First approved: Dec 11, 1958
Review: Standard
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Dec 11, 1958	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms


Diupres-250250MG;0.125MG · tablet;oral	Chlorothiazide; Reserpine	Discontinued
Diupres-500500MG;0.125MG · tablet;oral	Chlorothiazide; Reserpine	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Dec 16, 1994	Supplement 45Labeling · Standard review	Approved	None posted
Jul 7, 1994	Supplement 42Labeling	Approved	None posted
Mar 16, 1994	Supplement 44Manufacturing · Standard review	Approved	None posted
Sep 17, 1992	Supplement 43Labeling	Approved	None posted
Jul 1, 1988	Supplement 41Labeling	Approved	None posted
Apr 7, 1988	Supplement 40Manufacturing · Standard review	Approved	None posted
Dec 31, 1987	Supplement 38Manufacturing · Standard review	Approved	None posted
Aug 26, 1987	Supplement 39Labeling	Approved	None posted
Dec 11, 1958	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 11635
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