Methyclothiazide

ANDA 87913, held by Ivax Pharms. Methyclothiazide.

As of Nov 15, 2026, ANDA 87913 (Methyclothiazide), held by Ivax Pharms, was first approved by FDA on Jun 3, 1982, with 11 approved supplements and 0 published complete response letters.

First approved: Jun 3, 1982
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
Jun 3, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyclothiazide2.5MG · tablet;oral	Methyclothiazide	Discontinued

All 12 submissions, including labeling and manufacturing supplements


Jan 28, 2000	Supplement 11Manufacturing	Approved	None posted
Nov 23, 1999	Supplement 10Manufacturing	Approved	None posted
Aug 20, 1999	Supplement 9Manufacturing	Approved	None posted
Dec 9, 1998	Supplement 8Manufacturing	Approved	None posted
May 30, 1997	Supplement 7Manufacturing	Approved	None posted
Oct 24, 1995	Supplement 6Manufacturing	Approved	None posted
Oct 21, 1994	Supplement 5Manufacturing	Approved	None posted
Dec 4, 1992	Supplement 4Manufacturing	Approved	None posted
Nov 5, 1992	Supplement 3Labeling	Approved	None posted
Nov 4, 1982	Supplement 2Manufacturing	Approved	None posted
Nov 4, 1982	Supplement 1Manufacturing	Approved	None posted
Jun 3, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87913
Drugs@FDA: Overview at FDA
Company: IVAX 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