Chlorthalidone

ANDA 87706, held by Ani Pharms. Chlorthalidone.

As of Nov 15, 2026, ANDA 87706 (Chlorthalidone), held by Ani Pharms, was first approved by FDA on Sep 16, 1981, with 14 approved supplements and 0 published complete response letters.

First approved: Sep 16, 1981
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Sep 16, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorthalidone25MG · tablet;oral	Chlorthalidone	Discontinued

All 15 submissions, including labeling and manufacturing supplements


Sep 14, 1994	Supplement 19Manufacturing	Approved	None posted
Mar 4, 1994	Supplement 17Labeling	Approved	None posted
May 31, 1991	Supplement 15Manufacturing	Approved	None posted
Jan 28, 1991	Supplement 16Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 14Manufacturing	Approved	None posted
Mar 24, 1989	Supplement 13Labeling	Approved	None posted
Apr 13, 1988	Supplement 9Manufacturing	Approved	None posted
Apr 13, 1988	Supplement 10Manufacturing	Approved	None posted
Apr 13, 1988	Supplement 11Manufacturing	Approved	None posted
Aug 29, 1985	Supplement 6Manufacturing	Approved	None posted
Mar 11, 1985	Supplement 5Manufacturing	Approved	None posted
Jun 29, 1984	Supplement 4Manufacturing	Approved	None posted
Jan 30, 1984	Supplement 3Manufacturing	Approved	None posted
Feb 25, 1983	Supplement 1Manufacturing	Approved	None posted
Sep 16, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87706
Drugs@FDA: Overview at FDA
Company: ANI 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