Hydrochlorothiazide

Manages hypertension. ANDA 85182, held by Heritage. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 85182 (Hydrochlorothiazide), held by Heritage, was first approved by FDA on Jan 20, 1978, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 20, 1978
Supplements approved: 8
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 20, 1978	Original application	Approved	None posted

Products

3 strengths and forms


Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Rx
Hydrochlorothiazide25MG · tablet;oral	Hydrochlorothiazide	Rx
Hydrochlorothiazide12.5MG · tablet;oral	Hydrochlorothiazide	Rx

All 9 submissions, including labeling and manufacturing supplements


Mar 16, 2023	Supplement 43Labeling · Standard review	Approved	None posted
Aug 20, 2020	Supplement 38Labeling · Standard review	Approved	None posted
Jul 29, 2020	Supplement 37Labeling · Standard review	Approved	None posted
Apr 17, 1986	Supplement 18Manufacturing	Approved	None posted
Apr 17, 1986	Supplement 19Manufacturing	Approved	None posted
Nov 29, 1985	Supplement 15Manufacturing	Approved	None posted
Nov 29, 1985	Supplement 16Manufacturing	Approved	None posted
Nov 29, 1985	Supplement 17Manufacturing	Approved	None posted
Jan 20, 1978	Original application	Approved	None posted

Identifiers

Application: ANDA 85182
Drugs@FDA: Overview at FDA
Company: Heritage 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