Luvox

NDA 20243, held by Solvay. Fluvoxamine Maleate.

As of Nov 13, 2026, NDA 20243 (Luvox), held by Solvay, was first approved by FDA on Dec 5, 1994, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 5, 1994
Review: Standard
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Sep 28, 2000	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Letter
Mar 25, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 5, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

4 strengths and forms

Product	Active ingredient	Marketing
Luvox25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluvoxamine Maleate	DiscontinuedReference drug
Luvox50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluvoxamine Maleate	DiscontinuedReference drug
Luvox100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluvoxamine Maleate	DiscontinuedReference drug
Luvox150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Fluvoxamine Maleate	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 6, 2001	Supplement 23Labeling · Standard review	Approved	None posted
Sep 28, 2000	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Review Letter
Aug 9, 2000	Supplement 22Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 20Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 19Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Jun 1, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Oct 21, 1999	Supplement 18Manufacturing · Standard review	Approved	None posted
Dec 8, 1998	Supplement 15Labeling · Standard review	Approved	None posted
Mar 25, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 2, 1996	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 13, 1996	Supplement 9Labeling · Standard review	Approved	None posted
Aug 29, 1996	Supplement 7Manufacturing · Standard review	Approved	None posted
Mar 19, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Jan 18, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Aug 14, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Apr 12, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Feb 21, 1995	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 5, 1994	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20243
Drugs@FDA: Overview at FDA
Company: Solvay

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