Lozol

NDA 18538, held by Sanofi Aventis US. Indapamide.

As of Nov 13, 2026, NDA 18538 (Lozol), held by Sanofi Aventis US, was first approved by FDA on Jul 6, 1983, with 29 approved supplements and 0 published complete response letters.

First approved: Jul 6, 1983
Review: Standard
Supplements approved: 29
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 30 submissions below

Date	Submission	Status	Documents
Apr 29, 1993	Supplement 17Efficacy (new indication or use)	Approved	None posted
Jul 6, 1983	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Lozol2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Indapamide	DiscontinuedReference drug
Lozol1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Indapamide	DiscontinuedReference drug

All 30 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 2, 2021	Supplement 30Labeling · Standard review	Approved	Letter Label
Sep 3, 2009	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 10, 2000	Supplement 26Labeling · Standard review	Approved	None posted
Mar 7, 2000	Supplement 27Manufacturing · Standard review	Approved	None posted
Dec 11, 1998	Supplement 25Manufacturing · Standard review	Approved	None posted
Jan 27, 1998	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 29, 1996	Supplement 21Labeling · Standard review	Approved	None posted
Oct 29, 1996	Supplement 20Labeling · Standard review	Approved	None posted
May 16, 1996	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 26, 1996	Supplement 23Manufacturing · Standard review	Approved	None posted
Aug 19, 1993	Supplement 18Manufacturing · Standard review	Approved	None posted
Apr 29, 1993	Supplement 17Efficacy (new indication or use)	Approved	None posted
Mar 31, 1993	Supplement 19Labeling · Standard review	Approved	None posted
Jun 24, 1992	Supplement 16Labeling	Approved	None posted
Jun 23, 1992	Supplement 13Manufacturing · Standard review	Approved	None posted
Apr 1, 1992	Supplement 15Manufacturing · Standard review	Approved	None posted
Sep 25, 1991	Supplement 14Labeling	Approved	None posted
Mar 8, 1990	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 3, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 13, 1989	Supplement 11Manufacturing · Standard review	Approved	None posted
Jul 10, 1989	Supplement 10Manufacturing · Standard review	Approved	None posted
Feb 23, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 29, 1988	Supplement 7Manufacturing · Standard review	Approved	None posted
Nov 9, 1988	Supplement 6Labeling	Approved	None posted
Jul 8, 1988	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 30, 1987	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 10, 1984	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 29, 1983	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 12, 1983	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 6, 1983	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 18538
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