Hydrochlorothiazide

ANDA 83809, held by Whiteworth Town Plsn. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 83809 (Hydrochlorothiazide), held by Whiteworth Town Plsn, was first approved by FDA on Jul 2, 1974, with 1 approved supplement and 0 published complete response letters.

First approved: Jul 2, 1974
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jul 2, 1974	Original application	Approved	None posted

Products

2 strengths and forms


Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued
Hydrochlorothiazide25MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 20, 1984	Supplement 17Manufacturing	Approved	None posted
Jul 2, 1974	Original application	Approved	None posted

Identifiers

Application: ANDA 83809
Drugs@FDA: Overview at FDA
Company: Whiteworth Town Plsn

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