Chlorthalidone

ANDA 87296, held by Ani Pharms. Chlorthalidone.

As of Nov 15, 2026, ANDA 87296 (Chlorthalidone), held by Ani Pharms, was first approved by FDA on Aug 19, 1981, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 19, 1981
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Aug 19, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Chlorthalidone25MG · tablet;oral	Chlorthalidone	Discontinued

All 14 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
Jun 29, 1990	Supplement 14Manufacturing	Approved	None posted
Mar 29, 1988	Supplement 11Manufacturing	Approved	None posted
Mar 29, 1988	Supplement 12Manufacturing	Approved	None posted
Feb 11, 1988	Supplement 13Manufacturing	Approved	None posted
Aug 29, 1985	Supplement 7Manufacturing	Approved	None posted
Aug 29, 1985	Supplement 8Manufacturing	Approved	None posted
Mar 11, 1985	Supplement 6Manufacturing	Approved	None posted
May 15, 1984	Supplement 5Manufacturing	Approved	None posted
Jan 30, 1984	Supplement 2Manufacturing	Approved	None posted
Feb 25, 1983	Supplement 1Manufacturing	Approved	None posted
Aug 19, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87296
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