Lorelco

NDA 17535, held by Sanofi Aventis US. Probucol.

As of Nov 14, 2026, NDA 17535 (Lorelco), held by Sanofi Aventis US, was first approved by FDA on Feb 1, 1977, with 20 approved supplements and 0 published complete response letters.

First approved: Feb 1, 1977
Review: Priority
Supplements approved: 20
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Feb 1, 1977	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms


Lorelco250MG · tablet;oral	Probucol	Discontinued
Lorelco500MG · tablet;oral	Probucol	Discontinued

All 21 submissions, including labeling and manufacturing supplements


Aug 26, 1991	Supplement 46Manufacturing · Priority review	Approved	None posted
May 9, 1989	Supplement 45Manufacturing · Priority review	Approved	None posted
May 5, 1989	Supplement 43Manufacturing · Priority review	Approved	None posted
May 5, 1989	Supplement 42Manufacturing · Priority review	Approved	None posted
Jul 6, 1988	Supplement 41Manufacturing · Priority review	Approved	None posted
Jul 6, 1988	Supplement 40Labeling · Priority review	Approved	None posted
Mar 31, 1988	Supplement 37Manufacturing · Priority review	Approved	None posted
Jan 22, 1988	Supplement 38Manufacturing · Priority review	Approved	None posted
Feb 25, 1986	Supplement 36Labeling · Priority review	Approved	None posted
Aug 2, 1984	Supplement 33Manufacturing · Priority review	Approved	None posted
May 1, 1984	Supplement 30Manufacturing · Priority review	Approved	None posted
Apr 12, 1984	Supplement 31Labeling · Priority review	Approved	None posted
Nov 18, 1983	Supplement 29Manufacturing · Priority review	Approved	None posted
Sep 7, 1983	Supplement 28Labeling · Priority review	Approved	None posted
Dec 2, 1981	Supplement 23Manufacturing · Priority review	Approved	None posted
Oct 22, 1981	Supplement 22Manufacturing · Priority review	Approved	None posted
Jun 23, 1980	Supplement 17Manufacturing · Priority review	Approved	None posted
Apr 12, 1979	Supplement 6Labeling · Priority review	Approved	None posted
Apr 12, 1979	Supplement 1Labeling · Priority review	Approved	None posted
Mar 13, 1978	Supplement 8Manufacturing · Priority review	Approved	None posted
Feb 1, 1977	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 17535
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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