Hydrochlorothiazide

ANDA 85347, held by Whiteworth Town Plsn. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 85347 (Hydrochlorothiazide), held by Whiteworth Town Plsn, was first approved by FDA on Jan 26, 1978, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 26, 1978
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
Jan 26, 1978	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide100MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Jun 20, 1984	Supplement 2Manufacturing	Approved	None posted
Jan 26, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85347
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