Diuril

Manages hypertension. NDA 11870, held by Salix Pharms. Chlorothiazide.

As of Nov 13, 2026, NDA 11870 (Diuril), held by Salix Pharms, was first approved by FDA on Oct 6, 1961, with 24 approved supplements and 0 published complete response letters.

First approved: Oct 6, 1961
Review: Standard
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. DIURIL has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. DIURIL is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Use in Pregnancy - Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Oct 6, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Diuril250MG/5ML · suspension;oral	Chlorothiazide	DiscontinuedReference drug

All 25 submissions, including labeling and manufacturing supplements


Jun 10, 2009	Supplement 40Labeling · Standard review	Approved	Letter Label
Apr 2, 2009	Supplement 41Manufacturing	Approved	None posted
Aug 6, 2007	Supplement 39Labeling · Standard review	Approved	Letter
Aug 10, 2005	Supplement 37Labeling · Standard review	Approved	Letter
Sep 23, 2004	Supplement 36Labeling · Standard review	Approved	Letter
Sep 26, 2002	Supplement 35Manufacturing · Standard review	Approved	None posted
Apr 12, 2001	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 25, 2000	Supplement 32Manufacturing · Standard review	Approved	None posted
Dec 9, 1998	Supplement 31Labeling · Standard review	Approved	None posted
May 23, 1995	Supplement 30Labeling · Standard review	Approved	None posted
Feb 16, 1994	Supplement 29Labeling	Approved	None posted
Mar 2, 1993	Supplement 27Labeling	Approved	None posted
May 8, 1987	Supplement 19Labeling	Approved	None posted
Jan 13, 1986	Supplement 23Labeling	Approved	None posted
Nov 4, 1985	Supplement 22Labeling	Approved	None posted
Aug 28, 1984	Supplement 21Labeling	Approved	None posted
Mar 6, 1984	Supplement 20Labeling	Approved	None posted
Jan 13, 1981	Supplement 18Labeling	Approved	None posted
Oct 31, 1979	Supplement 17Labeling	Approved	None posted
Oct 31, 1979	Supplement 15Labeling	Approved	None posted
Oct 31, 1979	Supplement 14Labeling	Approved	None posted
Jul 13, 1979	Supplement 16Labeling	Approved	None posted
Jul 31, 1978	Supplement 13Labeling	Approved	None posted
Mar 27, 1975	Supplement 6REMS · Standard review	Approved	None posted
Oct 6, 1961	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 11870
Drugs@FDA: Overview at FDA
Company: Salix Pharmaceuticals

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