Chlorthalidone

ANDA 87176, held by Ivax Pharms. Chlorthalidone.

As of Nov 15, 2026, ANDA 87176 (Chlorthalidone), held by Ivax Pharms, was first approved by FDA on Apr 13, 1981, with 11 approved supplements and 0 published complete response letters.

First approved: Apr 13, 1981
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Apr 13, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorthalidone50MG · tablet;oral	Chlorthalidone	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jul 29, 2002	Supplement 21Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 20Manufacturing	Approved	None posted
Jul 1, 1998	Supplement 19Manufacturing	Approved	None posted
Mar 26, 1996	Supplement 16Manufacturing	Approved	None posted
Mar 26, 1996	Supplement 17Manufacturing	Approved	None posted
Mar 26, 1996	Supplement 18Manufacturing	Approved	None posted
Jan 27, 1995	Supplement 15Labeling	Approved	None posted
Mar 8, 1993	Supplement 14Labeling	Approved	None posted
Feb 5, 1985	Supplement 7Manufacturing	Approved	None posted
Feb 5, 1985	Supplement 8Manufacturing	Approved	None posted
Aug 10, 1983	Supplement 4Manufacturing	Approved	None posted
Apr 13, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87176
Drugs@FDA: Overview at FDA
Company: IVAX 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