Application 020204

Type: NDA
Sponsor: BAYER

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ALEVE	NAPROXEN SODIUM	TABLET;ORAL	220MG	Yes	Yes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0280-0041	Aleve Headache Pain	Naproxen Sodium	Bayer HealthCare LLC	NDA	Current
0280-0041	Aleve Headache Pain	Naproxen Sodium	Bayer HealthCare LLC	NDA	Current
0280-0270	Menstridol	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-0270	Menstridol	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-0270	Menstridol	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6000	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6010	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6020	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6050	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6060	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6070	Aleve	NAPROXEN SODIUM	Bayer HealthCare LLC.	NDA	Current
0280-6092	Aleve Back and Muscle Pain	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6092	Aleve Back and Muscle Pain	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6092	Aleve Back and Muscle Pain	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current
0280-6092	Aleve Back and Muscle Pain	Naproxen Sodium	Bayer HealthCare LLC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85325	SUPPL	2026-03-12
85324	SUPPL	2026-03-12
82098	SUPPL	2025-05-01
82097	SUPPL	2025-05-01
79607	SUPPL	2024-09-16
79604	SUPPL	2024-09-16
74486	SUPPL	2023-06-13
74475	SUPPL	2023-06-13
70520	SUPPL	2022-03-15
70482	SUPPL	2022-03-11
67170	SUPPL	2021-04-23
67108	SUPPL	2021-04-19
67107	SUPPL	2021-04-19
67106	SUPPL	2021-04-19
67105	SUPPL	2021-04-19
66989	SUPPL	2021-04-05
66330	SUPPL	2021-02-23
65809	SUPPL	2021-01-04
65808	SUPPL	2021-01-04
65807	SUPPL	2021-01-04
65806	SUPPL	2021-01-04
65114	SUPPL	2020-11-02
62894	SUPPL	2020-05-11
62893	SUPPL	2020-05-11
62672	SUPPL	2020-04-24
62671	SUPPL	2020-04-24
62030	SUPPL	2020-03-04
62029	SUPPL	2020-03-04
59666	SUPPL	2019-08-13
59667	SUPPL	2019-08-12
59439	SUPPL	2019-07-24
59438	SUPPL	2019-07-24
59234	SUPPL	2019-07-05
59233	SUPPL	2019-07-05
58721	SUPPL	2019-05-15
58720	SUPPL	2019-05-15
58719	SUPPL	2019-05-15
57513	SUPPL	2019-02-13
57455	SUPPL	2019-02-06
57119	SUPPL	2019-01-04
57117	SUPPL	2019-01-04
55928	SUPPL	2018-10-15
55737	SUPPL	2018-10-01
55367	SUPPL	2018-08-30
55366	SUPPL	2018-08-30
55112	SUPPL	2018-08-03
55007	SUPPL	2018-07-26
54623	SUPPL	2018-06-20
54622	SUPPL	2018-06-20
54596	SUPPL	2018-06-14
54588	SUPPL	2018-06-14
53588	SUPPL	2018-04-01
53578	SUPPL	2018-04-01
53510	SUPPL	2018-03-29
53499	SUPPL	2018-03-28
49825	SUPPL	2017-09-21
49797	SUPPL	2017-09-19
49541	SUPPL	2017-08-25
49535	SUPPL	2017-08-24
12317	SUPPL	2016-06-17
34365	SUPPL	2014-01-14
34366	SUPPL	2013-11-21
24572	SUPPL	2013-04-23
2166	SUPPL	2013-02-08
24571	SUPPL	2013-01-07
24570	SUPPL	2012-03-19
24569	SUPPL	2012-03-19
24568	SUPPL	2011-04-11
2165	SUPPL	2011-02-24
24567	SUPPL	2010-11-08
24566	SUPPL	2009-04-21
2164	SUPPL	2008-11-26
2163	SUPPL	2006-01-20
23572	ORIG	2005-07-28
12316	SUPPL	2005-05-05
2162	SUPPL	2005-05-05
24565	SUPPL	2004-03-24
2161	SUPPL	2002-08-30
2160	SUPPL	2002-03-19
24564	SUPPL	2001-03-06

Application 020204

Related Records#

Application Products#

NDC Listings For This Application#

Documents#