Enduron

NDA 12524, held by Abbvie. Methyclothiazide.

As of Nov 13, 2026, NDA 12524 (Enduron), held by Abbvie, was first approved by FDA on Oct 21, 1960, with 7 approved supplements and 0 published complete response letters.

First approved: Oct 21, 1960
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Oct 21, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms


Enduron2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Methyclothiazide	DiscontinuedReference drug
Enduron5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Methyclothiazide	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Apr 16, 1998	Supplement 34Manufacturing · Standard review	Approved	None posted
Jul 26, 1988	Supplement 29Labeling · Standard review	Approved	None posted
Aug 29, 1986	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 25, 1984	Supplement 31Manufacturing · Standard review	Approved	None posted
Jun 23, 1982	Supplement 30Labeling · Standard review	Approved	None posted
Jun 15, 1981	Supplement 26Labeling · Standard review	Approved	None posted
Jun 15, 1981	Supplement 27Labeling · Standard review	Approved	None posted
Oct 21, 1960	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 12524
Drugs@FDA: Overview at FDA
Company: AbbVie

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