Hydrochlorothiazide

ANDA 40809, held by Jubilant Cadista. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 40809 (Hydrochlorothiazide), held by Jubilant Cadista, was first approved by FDA on Sep 4, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Sep 4, 2007
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 4, 2007	Original application	Approved	None posted

Products

2 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Aug 20, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Sep 4, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 40809
Drugs@FDA: Overview at FDA
Company: Jubilant Cadista 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