Hydrochlorothiazide

ANDA 81190, held by Watson Labs. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 81190 (Hydrochlorothiazide), held by Watson Labs, was first approved by FDA on Jan 24, 1992, with 5 approved supplements and 0 published complete response letters.

First approved: Jan 24, 1992
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jan 24, 1992	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide100MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Dec 13, 1995	Supplement 4Labeling	Approved	None posted
Sep 12, 1995	Supplement 3Labeling	Approved	None posted
Aug 3, 1993	Supplement 2Labeling	Approved	None posted
Oct 6, 1992	Supplement 1Labeling	Approved	None posted
Jan 24, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 81190
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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