Aleve

NDA 20204, held by Bayer. Naproxen Sodium.

As of Nov 13, 2026, NDA 20204 (Aleve), held by Bayer, was first approved by FDA on Jan 11, 1994, with 63 approved supplements and 0 published complete response letters.

First approved: Jan 11, 1994
Review: Standard
Supplements approved: 63
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 64 submissions below

Date	Submission	Status	Documents
Jan 11, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Aleve220MG · tablet;oral	Naproxen Sodium	OTCReference drug

All 64 submissions, including labeling and manufacturing supplements


Mar 10, 2026	Supplement 90Labeling · Standard review	Approved	Letter Label
Apr 24, 2025	Supplement 89Labeling · Standard review	Approved	Letter Letter
Sep 11, 2024	Supplement 88Labeling · Standard review	Approved	Letter Label
Apr 4, 2023	Supplement 84Manufacturing	Approved	Letter Label
Mar 10, 2022	Supplement 83Labeling · Standard review	Approved	Label Letter
Apr 1, 2021	Supplement 81Labeling · Standard review	Approved	Label Letter
Dec 31, 2020	Supplement 77Labeling · Standard review	Approved	Label Letter
Dec 31, 2020	Supplement 78Labeling · Standard review	Approved	Label Letter
Dec 31, 2020	Supplement 79Labeling · Standard review	Approved	Label Letter
Dec 31, 2020	Supplement 80Labeling · Standard review	Approved	Label Letter
Oct 28, 2020	Supplement 76Labeling · Standard review	Approved	Label Letter
May 8, 2020	Supplement 72Labeling · Standard review	Approved	Label Letter
Apr 23, 2020	Supplement 71Labeling · Standard review	Approved	Label Letter
Mar 2, 2020	Supplement 70Labeling · Standard review	Approved	Letter Label
Aug 7, 2019	Supplement 68Labeling · Standard review	Approved	Letter Label
Jul 23, 2019	Supplement 67Labeling · Standard review	Approved	Letter Label
Jul 2, 2019	Supplement 66Labeling · Standard review	Approved	Letter Label
May 13, 2019	Supplement 63Labeling · Standard review	Approved	Letter
May 13, 2019	Supplement 64Labeling · Standard review	Approved	Label Letter
May 13, 2019	Supplement 65Labeling · Standard review	Approved	None posted
Jan 28, 2019	Supplement 61Labeling · Standard review	Approved	Letter Label
Jan 3, 2019	Supplement 62Labeling · Standard review	Approved	Label Letter
Sep 21, 2018	Supplement 59Labeling · Standard review	Approved	Label Letter
Aug 28, 2018	Supplement 58Labeling · Standard review	Approved	Letter Label
Jul 25, 2018	Supplement 57Labeling · Standard review	Approved	Label Letter
Jun 11, 2018	Supplement 56Labeling · Standard review	Approved	Label Letter
Jun 8, 2018	Supplement 55Labeling · Standard review	Approved	Label Letter
Mar 29, 2018	Supplement 54Labeling · Standard review	Approved	Letter Label
Mar 27, 2018	Supplement 53Labeling · Standard review	Approved	Letter Label
Sep 14, 2017	Supplement 52Labeling · Standard review	Approved	Label Letter
Aug 22, 2017	Supplement 51Labeling · Standard review	Approved	Letter Label
Jul 28, 2016	Supplement 49Manufacturing · Standard review	Approved	None posted
Feb 25, 2016	Supplement 48Manufacturing · Standard review	Approved	Label
Feb 4, 2015	Supplement 46Manufacturing · Standard review	Approved	None posted
Apr 18, 2013	Supplement 44Labeling · Standard review	Approved	Label Letter
Feb 7, 2013	Supplement 38Labeling · Standard review	Approved	Label Letter
Jan 7, 2013	Supplement 43Manufacturing · Standard review	Approved	None posted
Jan 3, 2013	Supplement 42Manufacturing · Standard review	Approved	Letter
Nov 13, 2012	Supplement 41Manufacturing · Standard review	Approved	None posted
Mar 16, 2012	Supplement 40Labeling · Standard review	Approved	Letter
Mar 15, 2012	Supplement 39Labeling · Standard review	Approved	Letter
Apr 8, 2011	Supplement 37Labeling · Standard review	Approved	Letter
Feb 18, 2011	Supplement 36Labeling · Standard review	Approved	Letter
Nov 3, 2010	Supplement 35Labeling · Standard review	Approved	Letter
Apr 15, 2009	Supplement 32Labeling · Standard review	Approved	Letter
Nov 24, 2008	Supplement 31Labeling · Standard review	Approved	Letter
Jan 6, 2006	Supplement 23Labeling · Standard review	Approved	Letter
May 4, 2005	Supplement 21Labeling · Standard review	Approved	Letter Label
Mar 22, 2004	Supplement 19Labeling · Standard review	Approved	Letter
Aug 30, 2002	Supplement 16Manufacturing · Standard review	Approved	Letter
Mar 19, 2002	Supplement 8Labeling · Standard review	Approved	Letter
Dec 21, 2001	Supplement 15Manufacturing · Standard review	Approved	None posted
Mar 27, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Mar 6, 2001	Supplement 7Labeling · Standard review	Approved	Letter
Jan 3, 2001	Supplement 13Manufacturing · Standard review	Approved	None posted
Aug 23, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Jun 7, 2000	Supplement 12Manufacturing · Standard review	Approved	None posted
May 11, 2000	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 20, 1998	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 16, 1998	Supplement 5Manufacturing · Standard review	Approved	None posted
Aug 1, 1996	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 10, 1995	Supplement 2Manufacturing · Standard review	Approved	None posted
Aug 12, 1994	Supplement 1Manufacturing · Standard review	Approved	None posted
Jan 11, 1994	Original applicationNew dosage form · Standard review	Approved	None posted

Show all 64

Identifiers

Application: NDA 20204
Drugs@FDA: Overview at FDA
Company: Bayer

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