Methyclothiazide

ANDA 89136, held by Par Pharm. Methyclothiazide.

As of Nov 15, 2026, ANDA 89136 (Methyclothiazide), held by Par Pharm, was first approved by FDA on Feb 12, 1986, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 12, 1986
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 12, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Methyclothiazide5MG · tablet;oral	Methyclothiazide	Discontinued

All 6 submissions, including labeling and manufacturing supplements


Apr 1, 1996	Supplement 7Manufacturing	Approved	None posted
Jan 16, 1992	Supplement 6Labeling	Approved	None posted
Dec 14, 1988	Supplement 5Labeling	Approved	None posted
May 13, 1988	Supplement 4Labeling	Approved	None posted
Sep 3, 1986	Supplement 1Manufacturing	Approved	None posted
Feb 12, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 89136
Drugs@FDA: Overview at FDA
Company: Par Pharmaceutical

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