Hydrochlorothiazide

ANDA 88587, held by Roxane. Hydrochlorothiazide.

As of Nov 15, 2026, ANDA 88587 (Hydrochlorothiazide), held by Roxane, was first approved by FDA on Jul 2, 1984, with 10 approved supplements and 0 published complete response letters.

First approved: Jul 2, 1984
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Jul 2, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Hydrochlorothiazide50MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;oral	Hydrochlorothiazide	DiscontinuedReference drug

All 11 submissions, including labeling and manufacturing supplements


Oct 25, 2001	Supplement 12Labeling	Approved	None posted
Sep 14, 1999	Supplement 11Manufacturing	Approved	None posted
Aug 28, 1996	Supplement 10Manufacturing	Approved	None posted
Mar 28, 1996	Supplement 9Manufacturing	Approved	None posted
Jul 6, 1994	Supplement 7Manufacturing	Approved	None posted
Jun 28, 1994	Supplement 8Labeling	Approved	None posted
Mar 1, 1993	Supplement 6Labeling	Approved	None posted
Apr 5, 1990	Supplement 5Labeling	Approved	None posted
Apr 21, 1988	Supplement 4Manufacturing	Approved	None posted
Apr 21, 1988	Supplement 3Manufacturing	Approved	None posted
Jul 2, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88587
Drugs@FDA: Overview at FDA
Company: Roxane 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