Enduronyl, Enduronyl Forte

NDA 12775, held by Abbott. Deserpidine; Methyclothiazide.

As of Nov 13, 2026, NDA 12775 (Enduronyl, Enduronyl Forte), held by Abbott, was first approved by FDA on Aug 1, 1961, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1961
Review: Standard
Supplements approved: 13
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Aug 1, 1961	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Enduronyl0.25MG;5MG · tablet;oral	Deserpidine; Methyclothiazide	Discontinued
Enduronyl Forte0.5MG;5MG · tablet;oral	Deserpidine; Methyclothiazide	Discontinued

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 16, 1998	Supplement 36Manufacturing · Standard review	Approved	None posted
Sep 25, 1991	Supplement 35Labeling · Standard review	Approved	None posted
Sep 25, 1991	Supplement 33Labeling · Standard review	Approved	None posted
Nov 17, 1987	Supplement 34Manufacturing · Standard review	Approved	None posted
Aug 29, 1986	Supplement 32Manufacturing · Standard review	Approved	None posted
Jul 28, 1986	Supplement 31Manufacturing · Standard review	Approved	None posted
Jan 5, 1984	Supplement 30Labeling · Standard review	Approved	None posted
Aug 25, 1982	Supplement 29Labeling · Standard review	Approved	None posted
Oct 5, 1981	Supplement 27Manufacturing · Standard review	Approved	None posted
May 22, 1981	Supplement 26Manufacturing · Standard review	Approved	None posted
Mar 27, 1981	Supplement 25Manufacturing · Standard review	Approved	None posted
Dec 12, 1980	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 3, 1980	Supplement 23Labeling · Standard review	Approved	None posted
Aug 1, 1961	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 12775
Drugs@FDA: Overview at FDA
Company: Abbott

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