Hydrochlorothiazide

ANDA 85098, held by Impax Labs. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 85098 (Hydrochlorothiazide), held by Impax Labs, was first approved by FDA on Jul 15, 1977, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 15, 1977
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jul 15, 1977	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide100MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Mar 16, 2001	Supplement 24Labeling	Approved	None posted
Mar 16, 2001	Supplement 25Labeling	Approved	None posted
Sep 18, 1991	Supplement 16Labeling	Approved	None posted
Jan 16, 1991	Supplement 23Labeling	Approved	None posted
Apr 6, 1990	Supplement 22Labeling	Approved	None posted
Jan 23, 1990	Supplement 21Labeling	Approved	None posted
Nov 9, 1989	Supplement 20Labeling	Approved	None posted
Jul 15, 1977	Original application	Approved	None posted

Identifiers

Application: ANDA 85098
Drugs@FDA: Overview at FDA
Company: Impax Laboratories

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