Chlorthalidone

ANDA 87381, held by Aiping Pharm Inc. Chlorthalidone.

As of Nov 15, 2026, ANDA 87381 (Chlorthalidone), held by Aiping Pharm Inc, was first approved by FDA on May 1, 1981, with 21 approved supplements and 0 published complete response letters.

First approved: May 1, 1981
Supplements approved: 21
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 22 submissions below

Date	Submission	Status	Documents
May 1, 1981	Original application	Approved	None posted

Products

2 strengths and forms


Chlorthalidone50MG · tablet;oral	Chlorthalidone	Discontinued
Chlorthalidone25MG · tablet;oral	Chlorthalidone	Discontinued

All 22 submissions, including labeling and manufacturing supplements


Apr 13, 2001	Supplement 25Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 24Manufacturing	Approved	None posted
Dec 30, 1997	Supplement 23Labeling	Approved	None posted
Feb 2, 1995	Supplement 21Manufacturing	Approved	None posted
Aug 19, 1994	Supplement 22Labeling	Approved	None posted
Apr 16, 1992	Supplement 20Manufacturing	Approved	None posted
May 9, 1991	Supplement 19Manufacturing	Approved	None posted
Dec 18, 1989	Supplement 18Labeling	Approved	None posted
Dec 8, 1987	Supplement 16Manufacturing	Approved	None posted
Jul 30, 1987	Supplement 15Manufacturing	Approved	None posted
Aug 16, 1985	Supplement 14Manufacturing	Approved	None posted
Jun 13, 1985	Supplement 13Manufacturing	Approved	None posted
Jun 13, 1985	Supplement 12Manufacturing	Approved	None posted
Jun 13, 1985	Supplement 11Manufacturing	Approved	None posted
Jun 13, 1985	Supplement 10Manufacturing	Approved	None posted
Jul 26, 1984	Supplement 9Manufacturing	Approved	None posted
Jul 26, 1984	Supplement 7Manufacturing	Approved	None posted
Jul 26, 1984	Supplement 6Manufacturing	Approved	None posted
May 9, 1984	Supplement 3Manufacturing	Approved	None posted
May 9, 1984	Supplement 2Manufacturing	Approved	None posted
Apr 8, 1983	Supplement 5Manufacturing	Approved	None posted
May 1, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87381
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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