Chlorthalidone

Manages hypertension. ANDA 86831, held by Mylan. Chlorthalidone.

As of Nov 15, 2026, ANDA 86831 (Chlorthalidone), held by Mylan, was first approved by FDA on Feb 26, 1981, with 15 approved supplements and 0 published complete response letters.

First approved: Feb 26, 1981
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below

Date	Submission	Status	Documents
Feb 26, 1981	Original application	Approved	None posted

Products

2 strengths and forms


Chlorthalidone50MG · tablet;oral	Chlorthalidone	RxReference drug
Chlorthalidone25MG · tablet;oral	Chlorthalidone	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Aug 22, 2002	Supplement 31Manufacturing	Approved	None posted
Dec 10, 1999	Supplement 30Manufacturing	Approved	None posted
Feb 25, 1998	Supplement 29Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 28Manufacturing	Approved	None posted
Dec 20, 1993	Supplement 27Manufacturing	Approved	None posted
Jun 21, 1993	Supplement 26Labeling	Approved	Label
Jan 13, 1992	Supplement 24Labeling	Approved	None posted
Sep 20, 1991	Supplement 23Labeling	Approved	None posted
Jan 31, 1990	Supplement 22Manufacturing	Approved	None posted
Dec 19, 1989	Supplement 21Labeling	Approved	None posted
Mar 29, 1988	Supplement 20Manufacturing	Approved	None posted
Oct 19, 1987	Supplement 19Manufacturing	Approved	None posted
Mar 15, 1985	Supplement 16Manufacturing	Approved	None posted
Aug 24, 1984	Supplement 15Manufacturing	Approved	None posted
Jun 24, 1982	Supplement 1Manufacturing	Approved	None posted
Feb 26, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 86831
Drugs@FDA: Overview at FDA
Company: Mylan

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