Hydrochlorothiazide

ANDA 84658, held by Ivax Sub Teva Pharms. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 84658 (Hydrochlorothiazide), held by Ivax Sub Teva Pharms, was first approved by FDA on Sep 24, 1975, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 24, 1975
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Sep 24, 1975	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 28, 1988	Supplement 22Labeling	Approved	None posted
Sep 24, 1975	Original application	Approved	None posted

Identifiers

Application: ANDA 84658
Drugs@FDA: Overview at FDA
Company: IVAX 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