Luvox

Treats obsessions and compulsions. NDA 21519, held by Ani Pharms. Fluvoxamine Maleate.

As of Nov 14, 2026, NDA 21519 (Luvox), held by Ani Pharms, was first approved by FDA on Dec 20, 2007, with 13 approved supplements and 0 published complete response letters.

First approved: Dec 20, 2007
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Fluvoxamine Maleate Tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD). 1.1 Obsessive-Compulsive Disorder

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Dec 20, 2007	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

3 strengths and forms


Luvox25MG · tablet;oral	Fluvoxamine Maleate	RxReference drug
Luvox50MG · tablet;oral	Fluvoxamine Maleate	RxReference drug
Luvox100MG · tablet;oral	Fluvoxamine Maleate	RxReference drug

All 14 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 26Labeling · Standard review	Approved	Letter Label Medication Guide
Sep 20, 2022	Supplement 21Manufacturing	Approved	Letter
Sep 20, 2021	Supplement 18Labeling	Approved	Letter Label
Dec 16, 2019	Supplement 12Labeling · Standard review	Approved	Letter Label
Jan 4, 2017	Supplement 9Labeling	Approved	Letter Label
Oct 23, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 8Labeling	Approved	Label Letter
Jul 10, 2013	Supplement 6Manufacturing · Standard review	Approved	None posted
May 28, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
May 24, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 30, 2012	Supplement 3Labeling · Standard review	Approved	Label Letter
Mar 16, 2011	Supplement 2Labeling	Approved	Letter Label
Feb 24, 2009	Supplement 1Labeling · Standard review	Approved	Label Letter
Dec 20, 2007	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 21519
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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