Hydrochlorothiazide

ANDA 85219, held by Aurolife Pharma LLC. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 85219 (Hydrochlorothiazide), held by Aurolife Pharma LLC, was first approved by FDA on Mar 12, 1979, with 8 approved supplements and 0 published complete response letters.

First approved: Mar 12, 1979
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Mar 12, 1979	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 9 submissions, including labeling and manufacturing supplements


Mar 28, 1995	Supplement 16Manufacturing	Approved	None posted
Aug 17, 1993	Supplement 19Labeling	Approved	None posted
Mar 29, 1993	Supplement 18Labeling	Approved	None posted
Oct 19, 1992	Supplement 17Labeling	Approved	None posted
Nov 2, 1989	Supplement 14Labeling	Approved	None posted
Apr 6, 1987	Supplement 9Manufacturing	Approved	None posted
Apr 6, 1987	Supplement 12Manufacturing	Approved	None posted
Sep 30, 1982	Supplement 7Manufacturing	Approved	None posted
Mar 12, 1979	Original application	Approved	None posted

Identifiers

Application: ANDA 85219
Drugs@FDA: Overview at FDA
Company: Aurolife Pharma

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