Hydrochlorothiazide

ANDA 88829, held by Superpharm. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 88829 (Hydrochlorothiazide), held by Superpharm, was first approved by FDA on Dec 28, 1984, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 28, 1984
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
Dec 28, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide100MG · tablet;oral	Hydrochlorothiazide	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Oct 30, 1989	Supplement 7Labeling	Approved	None posted
Jul 13, 1988	Supplement 6Labeling	Approved	None posted
Dec 28, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88829
Drugs@FDA: Overview at FDA
Company: Superpharm

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