Hydrochlorothiazide

ANDA 40807, held by Ipca Labs Ltd. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 40807 (Hydrochlorothiazide), held by Ipca Labs Ltd, was first approved by FDA on Jul 20, 2007, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2007
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jul 20, 2007	Original application	Approved	None posted

Products

3 strengths and forms


Hydrochlorothiazide12.5MG · tablet;oral	Hydrochlorothiazide	Discontinued
Hydrochlorothiazide25MG · tablet;oral	Hydrochlorothiazide	Discontinued
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Oct 13, 2011	Supplement 11Labeling	Approved	None posted
Oct 19, 2009	Supplement 3Labeling	Approved	None posted
Jul 20, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40807
Drugs@FDA: Overview at FDA
Company: Ipca 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