Hydrochlorothiazide

ANDA 85208, held by Actavis Elizabeth. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 85208 (Hydrochlorothiazide), held by Actavis Elizabeth, was first approved by FDA on Aug 20, 1981, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 20, 1981
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Aug 20, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 39Labeling · Standard review	Approved	None posted
Dec 23, 2002	Supplement 25Manufacturing	Approved	None posted
Jul 17, 2002	Supplement 24Manufacturing	Approved	None posted
Nov 2, 2001	Supplement 23Manufacturing	Approved	None posted
Feb 21, 2001	Supplement 22Manufacturing	Approved	None posted
Dec 13, 1999	Supplement 21Labeling	Approved	None posted
Jan 18, 1996	Supplement 20Manufacturing	Approved	None posted
Aug 2, 1995	Supplement 19Labeling	Approved	None posted
Aug 13, 1993	Supplement 18Labeling	Approved	None posted
Jan 28, 1993	Supplement 17Labeling	Approved	None posted
Jun 19, 1992	Supplement 16Labeling	Approved	None posted
Aug 12, 1991	Supplement 15Manufacturing	Approved	None posted
Dec 4, 1990	Supplement 14Labeling	Approved	None posted
Nov 14, 1988	Supplement 12Labeling	Approved	None posted
Jun 17, 1988	Supplement 10Manufacturing	Approved	None posted
May 23, 1988	Supplement 11Labeling	Approved	None posted
May 21, 1987	Supplement 9Manufacturing	Approved	None posted
Dec 13, 1985	Supplement 6Manufacturing	Approved	None posted
May 24, 1982	Supplement 2Manufacturing	Approved	None posted
Aug 20, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 85208
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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