Methyclothiazide

ANDA 88724, held by Watson Labs. Methyclothiazide.

As of Nov 15, 2026, ANDA 88724 (Methyclothiazide), held by Watson Labs, was first approved by FDA on Sep 6, 1984, with 11 approved supplements and 0 published complete response letters.

First approved: Sep 6, 1984
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Sep 6, 1984	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyclothiazide5MG · tablet;oral	Methyclothiazide	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jul 17, 1998	Supplement 17Manufacturing	Approved	None posted
Mar 24, 1994	Supplement 14Manufacturing	Approved	None posted
Mar 24, 1994	Supplement 15Labeling	Approved	None posted
Jun 20, 1991	Supplement 16Labeling	Approved	None posted
Aug 15, 1988	Supplement 9Manufacturing	Approved	None posted
Jun 17, 1988	Supplement 7Manufacturing	Approved	None posted
Jun 17, 1988	Supplement 8Manufacturing	Approved	None posted
Jun 17, 1988	Supplement 10Manufacturing	Approved	None posted
Nov 17, 1987	Supplement 4Manufacturing	Approved	None posted
Nov 17, 1987	Supplement 5Manufacturing	Approved	None posted
Dec 27, 1985	Supplement 3Manufacturing	Approved	None posted
Sep 6, 1984	Original application	Approved	None posted

Identifiers

Application: ANDA 88724
Drugs@FDA: Overview at FDA
Company: Watson 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