Hydrochlorothiazide

ANDA 87610, held by Vangard. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 87610 (Hydrochlorothiazide), held by Vangard, was first approved by FDA on Dec 7, 1981, with 1 approved supplement and 0 published complete response letters.

First approved: Dec 7, 1981
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
Dec 7, 1981	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Feb 4, 1985	Supplement 3Manufacturing	Approved	None posted
Dec 7, 1981	Original application	Approved	None posted

Identifiers

Application: ANDA 87610
Drugs@FDA: Overview at FDA
Company: Vangard Labs

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