Methyclothiazide

ANDA 87786, held by Ivax Pharms. Methyclothiazide.

As of Nov 15, 2026, ANDA 87786 (Methyclothiazide), held by Ivax Pharms, was first approved by FDA on May 18, 1982, with 1 approved supplement and 0 published complete response letters.

First approved: May 18, 1982
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
May 18, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyclothiazide5MG · tablet;oral	Methyclothiazide	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Nov 4, 1992	Supplement 8Labeling	Approved	None posted
May 18, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87786
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