Hydrochlorothiazide

ANDA 40774, held by Apotex. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 40774 (Hydrochlorothiazide), held by Apotex, was first approved by FDA on Oct 3, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2007
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 3, 2007	Original application	Approved	None posted

Products

2 strengths and forms


Hydrochlorothiazide25MG · tablet;oral	Hydrochlorothiazide	Discontinued
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 4, 2008	Supplement 1Manufacturing	Approved	None posted
Apr 4, 2008	Supplement 2Manufacturing	Approved	None posted
Oct 3, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40774
Drugs@FDA: Overview at FDA
Company: Apotex

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