Hydrochlorothiazide

ANDA 85022, held by Ivax Sub Teva Pharms. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 85022 (Hydrochlorothiazide), held by Ivax Sub Teva Pharms, was first approved by FDA on Sep 1, 1977, with 23 approved supplements and 0 published complete response letters.

First approved: Sep 1, 1977
Supplements approved: 23
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Sep 1, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide100MG · tablet;oral	Hydrochlorothiazide	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Nov 15, 2002	Supplement 31Manufacturing	Approved	None posted
Aug 22, 2002	Supplement 29Manufacturing	Approved	None posted
Jul 29, 2002	Supplement 33Manufacturing	Approved	None posted
Mar 12, 2002	Supplement 32Manufacturing	Approved	None posted
Jan 28, 2000	Supplement 28Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 26Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 25Manufacturing	Approved	None posted
Apr 30, 1999	Supplement 24Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 23Manufacturing	Approved	None posted
May 13, 1998	Supplement 22Manufacturing	Approved	None posted
Jan 13, 1998	Supplement 21Manufacturing	Approved	None posted
May 30, 1997	Supplement 20Manufacturing	Approved	None posted
Feb 28, 1997	Supplement 19Manufacturing	Approved	None posted
Oct 6, 1995	Supplement 16Manufacturing	Approved	None posted
Aug 17, 1995	Supplement 18Labeling	Approved	None posted
Jun 7, 1993	Supplement 15Manufacturing	Approved	None posted
Jun 7, 1993	Supplement 14Labeling	Approved	None posted
Mar 12, 1993	Supplement 17Labeling	Approved	None posted
Feb 25, 1993	Supplement 13Manufacturing	Approved	None posted
Nov 3, 1989	Supplement 12Manufacturing	Approved	None posted
Nov 3, 1989	Supplement 11Manufacturing	Approved	None posted
Nov 3, 1989	Supplement 10Manufacturing	Approved	None posted
Aug 24, 1988	Supplement 1Bioequivalence	Approved	None posted
Sep 1, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85022
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