Methyclothiazide

ANDA 87672, held by Pharmobedient. Methyclothiazide.

As of Nov 15, 2026, ANDA 87672 (Methyclothiazide), held by Pharmobedient, was first approved by FDA on Aug 17, 1982, with 6 approved supplements and 0 published complete response letters.

First approved: Aug 17, 1982
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Aug 17, 1982	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyclothiazide5MG · tablet;oral	Methyclothiazide	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Feb 25, 1998	Supplement 9Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 8Manufacturing	Approved	None posted
Oct 15, 1993	Supplement 7Manufacturing	Approved	None posted
Jul 1, 1991	Supplement 5Labeling	Approved	None posted
Jan 31, 1990	Supplement 4Manufacturing	Approved	None posted
Dec 26, 1989	Supplement 3Labeling	Approved	None posted
Aug 17, 1982	Original application	Approved	None posted

Identifiers

Application: ANDA 87672
Drugs@FDA: Overview at FDA
Company: PharmoBedient

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