Hydrochlorothiazide

ANDA 84912, held by Chartwell Rx. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 84912 (Hydrochlorothiazide), held by Chartwell Rx, was first approved by FDA on Dec 17, 1976, with 28 approved supplements and 0 published complete response letters.

First approved: Dec 17, 1976
Supplements approved: 28
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Dec 17, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 29 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 71Labeling · Standard review	Approved	None posted
Aug 6, 2020	Supplement 70Labeling · Standard review	Approved	None posted
Dec 1, 1998	Supplement 69Manufacturing	Approved	None posted
Dec 1, 1998	Supplement 68Manufacturing	Approved	None posted
Jan 12, 1998	Supplement 67Manufacturing	Approved	None posted
Jul 27, 1995	Supplement 66Labeling	Approved	None posted
Mar 30, 1994	Supplement 64Labeling	Approved	None posted
Jan 24, 1994	Supplement 65Manufacturing	Approved	None posted
Aug 11, 1992	Supplement 63Labeling	Approved	None posted
Aug 21, 1990	Supplement 58Manufacturing	Approved	None posted
Aug 21, 1990	Supplement 57Manufacturing	Approved	None posted
Nov 21, 1989	Supplement 61Labeling	Approved	None posted
Nov 9, 1989	Supplement 62Labeling	Approved	None posted
Aug 23, 1989	Supplement 60Labeling	Approved	None posted
May 27, 1988	Supplement 59Labeling	Approved	None posted
Jun 3, 1987	Supplement 56Manufacturing	Approved	None posted
Jun 3, 1987	Supplement 55Manufacturing	Approved	None posted
Jun 3, 1987	Supplement 54Manufacturing	Approved	None posted
Jun 3, 1987	Supplement 53Manufacturing	Approved	None posted
Apr 23, 1985	Supplement 49Manufacturing	Approved	None posted
Apr 12, 1985	Supplement 50Manufacturing	Approved	None posted
Aug 17, 1983	Supplement 46Manufacturing	Approved	None posted
Aug 17, 1983	Supplement 45Manufacturing	Approved	None posted
Aug 9, 1982	Supplement 43Manufacturing	Approved	None posted
Jul 8, 1982	Supplement 41Manufacturing	Approved	None posted
Jul 8, 1982	Supplement 39Manufacturing	Approved	None posted
Jul 8, 1982	Supplement 37Manufacturing	Approved	None posted
Jul 8, 1982	Supplement 36Manufacturing	Approved	None posted
Dec 17, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84912
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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