Hydrochlorothiazide

Manages hypertension. ANDA 87068, held by Oxford Pharms. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 87068 (Hydrochlorothiazide), held by Oxford Pharms, was first approved by FDA on Nov 5, 1980, with 17 approved supplements and 0 published complete response letters.

First approved: Nov 5, 1980
Supplements approved: 17
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 has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide is 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 18 submissions below

Date	Submission	Status	Documents
Nov 5, 1980	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Rx

All 18 submissions, including labeling and manufacturing supplements


Oct 23, 2023	Supplement 24Labeling · Standard review	Approved	None posted
Aug 20, 2020	Supplement 22Labeling · Standard review	Approved	None posted
May 18, 2005	Supplement 19Labeling	Approved	None posted
May 7, 1999	Supplement 17Manufacturing	Approved	None posted
Feb 11, 1999	Supplement 16Manufacturing	Approved	None posted
Dec 30, 1998	Supplement 15Manufacturing	Approved	None posted
Aug 3, 1995	Supplement 14Labeling	Approved	None posted
Aug 4, 1994	Supplement 13Manufacturing	Approved	None posted
Jul 11, 1994	Supplement 10Manufacturing	Approved	None posted
Nov 22, 1993	Supplement 12Labeling	Approved	None posted
Aug 10, 1993	Supplement 11Labeling	Approved	None posted
May 26, 1992	Supplement 9Labeling	Approved	None posted
Nov 9, 1990	Supplement 8Labeling	Approved	None posted
Apr 20, 1990	Supplement 7Labeling	Approved	None posted
Nov 15, 1989	Supplement 6Labeling	Approved	None posted
Aug 15, 1983	Supplement 5Manufacturing	Approved	None posted
Jul 27, 1983	Supplement 4Manufacturing	Approved	None posted
Nov 5, 1980	Original application	Approved	None posted

Identifiers

Application: ANDA 87068
Drugs@FDA: Overview at FDA
Company: Oxford 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