Hydrochlorothiazide

ANDA 84324, held by Lannett Co Inc. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 84324 (Hydrochlorothiazide), held by Lannett Co Inc, was first approved by FDA on Jun 24, 1976, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 24, 1976
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jun 24, 1976	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 70Labeling · Standard review	Approved	None posted
Aug 18, 2011	Supplement 65Labeling	Approved	None posted
Mar 6, 2008	Supplement 59Labeling	Approved	None posted
Aug 6, 2007	Supplement 56Labeling	Approved	None posted
Jun 15, 1989	Supplement 55Manufacturing	Approved	None posted
Apr 10, 1989	Supplement 54Bioequivalence	Approved	None posted
Nov 22, 1983	Supplement 52Manufacturing	Approved	None posted
Nov 22, 1983	Supplement 53Manufacturing	Approved	None posted
Nov 23, 1982	Supplement 50Manufacturing	Approved	None posted
Nov 23, 1982	Supplement 51Manufacturing	Approved	None posted
Jun 24, 1976	Original application	Approved	None posted

Identifiers

Application: ANDA 84324
Drugs@FDA: Overview at FDA
Company: Lannett Company

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