Thalitone

Treats hypertension. NDA 19574, held by Casper Pharma LLC. Chlorthalidone.

As of Nov 13, 2026, NDA 19574 (Thalitone), held by Casper Pharma LLC, was first approved by FDA on Dec 20, 1988, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 20, 1988
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

THALITONE is a thiazide-like diuretic indicated:

For the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
as adjunctive therapy in edema associated with heart failure, cirrhosis of the liver, and renal disease, including nephrotic syndrome. 1.1 Hypertension THALITONE is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Dec 20, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Thalitone15MG · tablet;oral	Chlorthalidone	RxReference drug
Thalitone25MG · tablet;oral	Chlorthalidone	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 17, 2019	Supplement 17Labeling · Standard review	Approved	Label Letter
Apr 19, 2018	Supplement 16Labeling · Standard review	Approved	Label
Jun 1, 2004	Supplement 10Labeling · Standard review	Approved	Letter
Jun 21, 2001	Supplement 11Manufacturing · Standard review	Approved	None posted
Feb 11, 2000	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 16, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 23, 1997	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 26, 1995	Supplement 6Manufacturing · Standard review	Approved	None posted
Jun 27, 1994	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 8, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Jun 26, 1993	Supplement 3Labeling · Standard review	Approved	None posted
Oct 15, 1992	Supplement 2Labeling	Approved	None posted
Feb 12, 1992	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 20, 1988	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 19574
Drugs@FDA: Overview at FDA
Company: Casper Pharma

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