Hydrochlorothiazide

ANDA 83232, held by Watson Labs Teva. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 83232 (Hydrochlorothiazide), held by Watson Labs Teva, was first approved by FDA on Jan 24, 1975, with 23 approved supplements and 0 published complete response letters.

First approved: Jan 24, 1975
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
Jan 24, 1975	Original application	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 24 submissions, including labeling and manufacturing supplements


Dec 13, 1995	Supplement 57Labeling	Approved	None posted
Sep 12, 1995	Supplement 56Labeling	Approved	None posted
Aug 3, 1993	Supplement 55Labeling	Approved	None posted
Oct 6, 1992	Supplement 54Labeling	Approved	None posted
Nov 19, 1990	Supplement 53Manufacturing	Approved	None posted
Jun 29, 1990	Supplement 50Manufacturing	Approved	None posted
Jul 12, 1989	Supplement 51Labeling	Approved	None posted
May 4, 1989	Supplement 49Labeling	Approved	None posted
Sep 20, 1988	Supplement 47Labeling	Approved	None posted
Sep 20, 1988	Supplement 46Manufacturing	Approved	None posted
Sep 20, 1988	Supplement 45Manufacturing	Approved	None posted
Feb 19, 1988	Supplement 43Manufacturing	Approved	None posted
Feb 19, 1988	Supplement 42Manufacturing	Approved	None posted
Dec 16, 1987	Supplement 41Manufacturing	Approved	None posted
Dec 16, 1987	Supplement 40Manufacturing	Approved	None posted
Dec 16, 1987	Supplement 39Manufacturing	Approved	None posted
Jun 3, 1985	Supplement 34Manufacturing	Approved	None posted
Jun 3, 1985	Supplement 33Manufacturing	Approved	None posted
Jan 22, 1985	Supplement 32Manufacturing	Approved	None posted
Jan 13, 1984	Supplement 31Manufacturing	Approved	None posted
May 23, 1983	Supplement 29Manufacturing	Approved	None posted
May 23, 1983	Supplement 28Manufacturing	Approved	None posted
Aug 16, 1982	Supplement 26Manufacturing	Approved	None posted
Jan 24, 1975	Original application	Approved	Review

Identifiers

Application: ANDA 83232
Drugs@FDA: Overview at FDA
Company: Watson Labs Teva

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