Hydrochlorothiazide

ANDA 79237, held by Ipca Labs Ltd. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 79237 (Hydrochlorothiazide), held by Ipca Labs Ltd, was first approved by FDA on Apr 2, 2009, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 2, 2009
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
Apr 2, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide12.5MG · capsule;oral	Hydrochlorothiazide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Feb 1, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Aug 17, 2011	Supplement 5Labeling	Approved	None posted
Apr 2, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 79237
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