Naproxen Oral Tablet

Brand(s)
Aleve, Anaprox, Flanax Naproxen, Menstridol, Midol Extended Relief, Naprosyn, Rx-Act All Day Pain Relief
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Genentech, Inc. (2013-04-05)
Oldest Current Product
1976-03-11
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\NAPROXEN
FDAOB
ORAL\TABLET, DELAYED RELEASE\NAPROXEN
ORAL\TABLET\NAPROXEN
ORAL\TABLET\NAPROXEN SODIUM
SPL Active
ORAL\TABLET, COATED\NAPROXEN SODIUM
ORAL\TABLET, FILM COATED\NAPROXEN SODIUM
ORAL\TABLET\NAPROXEN
ORAL\TABLET\NAPROXEN SODIUM
SPL Moiety
ORAL\TABLET, COATED\NAPROXEN
ORAL\TABLET, FILM COATED\NAPROXEN
ORAL\TABLET\NAPROXEN

product(s) by strength(s)

naproxen 200 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1670600000ANDAAdvanced First Aid, Inc.2015-04-09NAPROXEN SODIUMORALTABLETANDA090545344f908c-934e-4c98-aeef-68fd09d47c72

naproxen 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000046313NaprosynNDAGenentech, Inc.1976-03-11NAPROXENORALTABLETNDA01758168848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930147ANDATeva Pharmaceuticals Usa Inc1993-12-22NAPROXENORALTABLETANDA074201177f0371-46e7-4527-8381-0067cad57025
2001431346ANDAWest-Ward Pharmaceutical Corp2004-01-14NAPROXENORALTABLETANDA076494b5a359c0-890e-4ac7-bc5e-f939f04344f5
3009046069ANDAMajor2009-08-10NAPROXENORALTABLETANDA075927907ba0f9-e4c9-49d4-9ff8-019739076324
4250000138ANDAMarksans Pharma Limited2011-02-28NAPROXENORALTABLETANDA0914161fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8
5317220340ANDACamber Pharmaceuticals, Inc.2012-01-23NAPROXENORALTABLETANDA0913058dd7fade-d750-49ce-b798-a1d3615e57b7
6526050138ANDAPolygen Pharmaceuticals Llc2012-02-01NAPROXENORALTABLETANDA0914162e84d479-5536-471f-93ef-34c353aff071
7537460188ANDAAmneal Pharmaceuticals, Llc2010-02-18NAPROXENORALTABLETANDA0759272718e0b7-1ce6-457e-bee9-11b634dfd353
8551110366ANDADr. Reddy'S Laboratories Ltd2004-06-05NAPROXENORALTABLETANDA075927fe7273f4-2a9a-187d-4ee0-f5f46db0bf58
9651620188ANDAAmneal Pharmaceuticals2010-02-18NAPROXENORALTABLETANDA075927c43a43e2-e867-448d-8f59-3efc7c077cbc
10658620520ANDAAurobindo Pharma Limited2011-11-08NAPROXENORALTABLETANDA2004290e5315bc-c02f-4749-be69-b5b528327d58
11684620188ANDAGlenmark Generics Inc., Usa2007-07-01NAPROXENORALTABLETANDA0782506c5bb008-e66f-4ef0-bf84-aca7eb5983e9

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009045535ANDAMajor2008-11-08NAPROXENORALTABLETANDA074410907ba0f9-e4c9-49d4-9ff8-019739076324

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006153562ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-07-18NAPROXENORALTABLET000930147ANDA0742018a2d541e-dfa2-4b37-9b18-ed72c7e4aafb
2009046295ANDAMajor2011-02-28NAPROXENORALTABLET250000138ANDA09141627540e0b-d8bd-4409-9e60-f44c55f5acb2
3216950084ANDARebel Distributors Corp2010-02-18NAPROXENORALTABLET537460188ANDA0759278c7b265e-7500-464a-854e-9c4a22c8d211
4332610128ANDAAidarex Pharmaceuticals Llc2010-02-18NAPROXENORALTABLET537460188ANDA075927f23569ab-d9ac-45e8-b8f3-8d0ba612fc2d
5422540158ANDARebel Distributors Corp2007-07-01NAPROXENORALTABLET684620188ANDA0782501e9675c8-bcff-4621-90f7-b80489e1b840
6430630092ANDAPd-Rx Pharmaceuticals, Inc.2004-01-14NAPROXENORALTABLET001431346ANDA0764946feaf2b5-62fb-47dd-a1ee-f101d7835235
7430630445ANDAPd-Rx Pharmaceuticals, Inc.2010-02-18NAPROXENORALTABLET537460188ANDA0759275492c64e-5223-40de-a24c-fea75cfd8a02
8430630600ANDAPd-Rx Pharmaceuticals, Inc.2010-02-18NAPROXENORALTABLET651620188ANDA0759276573681e-e9be-440f-a818-a533b744648e
9433530506ANDAAphena Pharma Solutions - Tennessee, Llc2009-08-10NAPROXENORALTABLET009046069ANDA075927502f390d-d69e-4a77-8a59-4eedf91004f3
10458650610ANDAMedsource Pharmaceuticals2007-07-01NAPROXENORALTABLET684620188ANDA0782501f7d2f11-5b62-1c90-e054-00144ff88e88
11502680594ANDAAvpak2015-02-05NAPROXENORALTABLET537460188ANDA075927e6fbf8f1-b064-658d-17bb-e7d6320aa45f
12504366607ANDAUnit Dose Services2010-02-18NAPROXENORALTABLET537460188ANDA075927399be983-e098-4f88-8410-088152fb3937
13516550685ANDANorthwind Pharmaceuticals, Llc2014-08-26NAPROXENORALTABLET684620188ANDA0782501d99ad89-82b1-4842-b624-f839aa5a31a9
14521250682ANDARemedyrepack Inc.2013-08-27NAPROXENORALTABLET537460188ANDA075927dc9789e4-b22a-47cb-95fa-df57ec68c80c
15538080615ANDAState Of Florida Doh Central Pharmacy2009-07-01NAPROXENORALTABLET537460188ANDA0759276b10c3ff-7cd9-4a59-9436-d2c6a64e4a69
16551541186ANDACardinal Health2010-02-18NAPROXENORALTABLET537460188ANDA075927a3a9858c-be31-41c0-ad55-551f05da4f0f
17551543397ANDACardinal Health2009-08-10NAPROXENORALTABLET009046069ANDA075927bd03ffa0-02a7-4b66-82f2-d080562d9f1c
18552890445ANDAPd-Rx Pharmaceuticals, Inc.2004-01-14NAPROXENORALTABLET001431346ANDA076494bbf83f37-fdc7-41b7-9b12-d8e68e8cc39b
19617860107ANDARemedyrepack Inc.2014-12-01NAPROXENORALTABLET651620188ANDA07592711158d37-0931-4744-9ff8-eee42916185b
20631870461ANDAProficient Rx Lp2007-07-01NAPROXENORALTABLET684620188ANDA078250aa4d159c-9cbe-4d29-9532-33a312f1ae05
21636293202NaprosynANDABryant Ranch Prepack2009-09-01NAPROXENORALTABLET537460188ANDA07592770e73a11-5951-43db-9cd2-dc851cd5fa7b
22638740301ANDAAltura Pharmaceuticals, Inc.2010-01-01NAPROXENORALTABLET684620188ANDA0782504bbe6e74-b13e-4609-b4cc-aa0b00d66df8
23670460499ANDAContract Pharmacy Services-Pa2010-03-19NAPROXENORALTABLET684620188ANDA0782502c4f826c-e71b-4462-a025-19730701a9de
24675440679ANDAAphena Pharma Solutions - Tennessee, Inc.2010-02-18NAPROXENORALTABLET537460188ANDA07592792c48cd9-e645-4871-a0ad-9ea56623edb6
25681512894ANDACarilion Materials Management2010-02-18NAPROXENORALTABLET537460188ANDA0759279f119b61-24fc-437a-b7b9-ff9939c094d5
26683870801ANDAKeltman Pharmaceuticals Inc.2009-04-27NAPROXENORALTABLET537460188ANDA0759271a10952e-0662-4f2c-bd02-28dd4eee138f

naproxen 375 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000046314NaprosynNDAGenentech, Inc.1976-03-11NAPROXENORALTABLETNDA01758168848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930148ANDATeva Pharmaceuticals Usa Inc1993-12-22NAPROXENORALTABLETANDA074201177f0371-46e7-4527-8381-0067cad57025
2001431347ANDAWest-Ward Pharmaceutical Corp2004-01-14NAPROXENORALTABLETANDA076494b5a359c0-890e-4ac7-bc5e-f939f04344f5
3009045590ANDAMajor2004-04-01NAPROXENORALTABLETANDA076494907ba0f9-e4c9-49d4-9ff8-019739076324
4250000139ANDAMarksans Pharma Limited2011-02-28NAPROXENORALTABLETANDA0914161fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8
5317220341ANDACamber Pharmaceuticals, Inc.2012-01-23NAPROXENORALTABLETANDA0913058dd7fade-d750-49ce-b798-a1d3615e57b7
6526050139ANDAPolygen Pharmaceuticals Llc2012-02-01NAPROXENORALTABLETANDA0914162e84d479-5536-471f-93ef-34c353aff071
7537460189ANDAAmneal Pharmaceuticals, Llc2010-02-18NAPROXENORALTABLETANDA0759272718e0b7-1ce6-457e-bee9-11b634dfd353
8551110367ANDADr. Reddy'S Laboratories Ltd2004-06-05NAPROXENORALTABLETANDA075927fe7273f4-2a9a-187d-4ee0-f5f46db0bf58
9651620189ANDAAmneal Pharmaceuticals2010-02-18NAPROXENORALTABLETANDA075927c43a43e2-e867-448d-8f59-3efc7c077cbc
10658620521ANDAAurobindo Pharma Limited2011-11-08NAPROXENORALTABLETANDA2004290e5315bc-c02f-4749-be69-b5b528327d58
11684620189ANDAGlenmark Generics Inc., Usa2007-07-01NAPROXENORALTABLETANDA0782506c5bb008-e66f-4ef0-bf84-aca7eb5983e9

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009045536ANDAMajor2008-11-08NAPROXENORALTABLETANDA074410907ba0f9-e4c9-49d4-9ff8-019739076324

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006151504ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-07-18NAPROXENORALTABLET000930148ANDA0742018a2d541e-dfa2-4b37-9b18-ed72c7e4aafb
2009046296ANDAMajor2011-02-28NAPROXENORALTABLET250000139ANDA09141627540e0b-d8bd-4409-9e60-f44c55f5acb2
3105440019ANDABlenheim Pharmacal, Inc.2010-09-24NAPROXENORALTABLET537460189ANDA07592797b051b0-65e1-4797-b72d-96f7ac623d1d
4105440277ANDABlenheim Pharmacal, Inc.2009-12-14NAPROXENORALTABLET684620189ANDA07825050954ade-19ad-40dd-8e06-0b33394895f7
5165900162ANDAStat Rx Usa Llc2010-02-18NAPROXENORALTABLET537460189ANDA075927f14e79d3-a8e9-46fd-9959-639343c1c642
6216950085ANDARebel Distributors Corp2010-02-18NAPROXENORALTABLET537460189ANDA0759278c7b265e-7500-464a-854e-9c4a22c8d211
7242360762ANDARemedyrepack Inc.2013-01-10NAPROXENORALTABLET537460189ANDA075927d3cbe699-d1a6-44a2-8c24-da8055bd009d
8332610080ANDAAidarex Pharmaceuticals Llc2010-02-18NAPROXENORALTABLET537460189ANDA0759272a6133ff-285d-4026-bbd6-e99f84b63820
9422540221ANDARebel Distributors Corp2007-07-01NAPROXENORALTABLET684620189ANDA07825087a90438-84b6-4485-b43a-d9b9a58b933a
10425490525ANDAStat Rx Usa Llc2004-01-14NAPROXENORALTABLET001431347ANDA0764940a27f628-8089-41ba-b45e-4f03551aeafd
11430630258ANDAPd-Rx Pharmaceuticals, Inc.2010-04-22NAPROXENORALTABLET003780555ANDA074121e81fa45e-cd3c-4422-b828-d780cc570469
12493490224ANDARemedyrepack Inc.2011-03-08NAPROXENORALTABLET537460189ANDA075927a5a77f2d-2833-4dd9-8839-95f0e63b1606
13499990049ANDALake Erie Medical Dba Quality Care Products Llc2011-11-04NAPROXENORALTABLET684620189ANDA0782500879f244-ec2f-4091-b0e3-ca9c1475ab21
14502680595ANDAAvpak2015-02-05NAPROXENORALTABLET537460189ANDA075927e6fbf8f1-b064-658d-17bb-e7d6320aa45f
15504366608ANDAUnit Dose Services2007-07-01NAPROXENORALTABLET684620189ANDA078250dd6dcaed-3e37-4aba-b1cf-e949184f78eb
16521250161ANDARemedyrepack Inc.2013-07-25NAPROXENORALTABLET684620189ANDA078250984654f9-6803-4702-822d-e4a151f4d27d
17521250190ANDARemedyrepack Inc.2012-12-28NAPROXENORALTABLET000930148ANDA074201cb8a73cd-960c-4569-b2d6-abbcd2096689
18521250419ANDARemedyrepack Inc.2013-05-15NAPROXENORALTABLET537460189ANDA075927c39b543c-3c82-4b73-8c3b-8c23fceab904, e84220bb-e466-4c4b-b53e-11f946e5190d
19521250436ANDARemedyrepack Inc.2013-05-15NAPROXENORALTABLET526050139ANDA0914167bb35a64-bdd0-49eb-9448-718b23f7cd86, d337a95d-9f50-40f2-bdc6-c736eef721eb
20521250667ANDARemedyrepack Inc.2013-07-09NAPROXENORALTABLET000930148ANDA074201c59ba3de-7ced-43de-9242-3498d6ccd59a
21521250858ANDARemedyrepack Inc.2014-03-03NAPROXENORALTABLET537460189ANDA0759273e820ab5-cebf-4613-9c33-c6b88c0f7497
22521250929ANDARemedyrepack Inc.2014-05-01NAPROXENORALTABLET317220341ANDA091305fedc8f43-01cb-488a-9fa6-959bbca7c293
23529590191ANDAH.J. Harkins Company, Inc.2007-07-01NAPROXENORALTABLET684620189ANDA078250b5331161-8f50-4598-b87d-1bee1e890873
24538080386ANDAState Of Florida Doh Central Pharmacy2009-07-01NAPROXENORALTABLET684620189ANDA078250d771185e-fee2-436c-aa96-36da8de3f611
25538080738ANDAState Of Florida Doh Central Pharmacy2009-07-01NAPROXENORALTABLET537460189ANDA0759276b10c3ff-7cd9-4a59-9436-d2c6a64e4a69
26551541187ANDACardinal Health2010-02-18NAPROXENORALTABLET537460189ANDA07592792c4b5e2-ef4b-4828-8d28-7e8c6f9ad0d9
27552890297ANDAPd-Rx Pharmaceuticals, Inc.2010-02-18NAPROXENORALTABLET537460189ANDA07592714bbb8c8-1d99-40b7-8f0a-1099df04d186
28581180189ANDAClinical Solutions Wholesale2010-02-18NAPROXENORALTABLET537460189ANDA0759278554e4e0-8ded-44d7-a7f7-bb45d5e45858
29617860100ANDARemedyrepack Inc.2014-11-26NAPROXENORALTABLET651620189ANDA075927e0843f9c-dd28-4233-9b0c-8d88619c9521
30631870535ANDAProficient Rx Lp2007-07-01NAPROXENORALTABLET684620189ANDA0782503e4e5371-d796-47c7-95c1-d99e82a0b282
31636291476ANDABryant Ranch Prepack2004-01-14NAPROXENORALTABLET001431347ANDA0764940dfe8f7c-3f12-494c-a0e4-ff9affcd8828
32638740325ANDAAltura Pharmaceuticals, Inc.2010-01-01NAPROXENORALTABLET684620189ANDA0782504bbe6e74-b13e-4609-b4cc-aa0b00d66df8
33663360817ANDADispensing Solutions, Inc.2010-02-18NAPROXENORALTABLET537460189ANDA075927413a5d58-f37c-4e50-bfc4-fe2000df25ac
34670460500ANDAContract Pharmacy Services-Pa2010-03-19NAPROXENORALTABLET684620189ANDA0782502c4f826c-e71b-4462-a025-19730701a9de
35675440456ANDAAphena Pharma Solutions - Tennessee, Inc.2010-02-18NAPROXENORALTABLET537460189ANDA07592792c48cd9-e645-4871-a0ad-9ea56623edb6
36681512895ANDACarilion Materials Management2007-07-01NAPROXENORALTABLET684620189ANDA07825048aff41b-59ea-4999-88b8-f95babdaee2b
37683870802ANDAKeltman Pharmaceuticals Inc.2010-10-04NAPROXENORALTABLET537460189ANDA0759271a10952e-0662-4f2c-bd02-28dd4eee138f
38687889878ANDAPreferred Pharmaceuticals, Inc.2015-08-14NAPROXENORALTABLET317220341ANDA091305476725b3-1d1f-4d48-9cfe-29a4b0b3c42a
39687889906ANDAPreferred Pharmaceuticals, Inc.2012-01-30NAPROXENORALTABLET537460189ANDA0759276d757241-53f8-4498-999a-87dfe3cb4d17

naproxen 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000046316NaprosynNDAGenentech, Inc.1976-03-11NAPROXENORALTABLETNDA01758168848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930149ANDATeva Pharmaceuticals Usa Inc1993-12-22NAPROXENORALTABLETANDA074201177f0371-46e7-4527-8381-0067cad57025
2001431348ANDAWest-Ward Pharmaceutical Corp2004-01-14NAPROXENORALTABLETANDA076494b5a359c0-890e-4ac7-bc5e-f939f04344f5
3009045591ANDAMajor2004-04-01NAPROXENORALTABLETANDA076494907ba0f9-e4c9-49d4-9ff8-019739076324
4250000140ANDAMarksans Pharma Limited2011-02-28NAPROXENORALTABLETANDA0914161fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8
5278540190Flanax NaproxenANDABelmora Llc2015-08-18NAPROXENORALTABLETANDA0759273788887f-bf34-4f1b-b26a-3138d4ee44b9
6317220342ANDACamber Pharmaceuticals, Inc.2012-01-23NAPROXENORALTABLETANDA0913058dd7fade-d750-49ce-b798-a1d3615e57b7
7458610012ANDAPharmaceutica North America, Inc2013-08-07NAPROXENORALTABLETANDA0914326cc2c511-5395-4e3d-806e-60dcd7191945
8458610102ANDAPharmaceutica North America, Inc2013-08-28ANDA091432ecdd0ba4-adfa-4cd5-99c5-790512b860e7
9526050140ANDAPolygen Pharmaceuticals Llc2012-02-01NAPROXENORALTABLETANDA0914162e84d479-5536-471f-93ef-34c353aff071
10537460190ANDAAmneal Pharmaceuticals, Llc2010-02-18NAPROXENORALTABLETANDA0759272718e0b7-1ce6-457e-bee9-11b634dfd353
11551110368ANDADr. Reddy'S Laboratories Ltd2004-06-05NAPROXENORALTABLETANDA075927fe7273f4-2a9a-187d-4ee0-f5f46db0bf58
12552890466ANDAPd-Rx Pharmaceuticals, Inc.2010-02-18ANDA07592791802fa6-ddf3-4356-85f0-2032cf31478b
13651620190ANDAAmneal Pharmaceuticals2010-02-18NAPROXENORALTABLETANDA075927c43a43e2-e867-448d-8f59-3efc7c077cbc
14658620522ANDAAurobindo Pharma Limited2011-11-08NAPROXENORALTABLETANDA2004290e5315bc-c02f-4749-be69-b5b528327d58
15684620190ANDAGlenmark Generics Inc., Usa2007-07-01NAPROXENORALTABLETANDA0782506c5bb008-e66f-4ef0-bf84-aca7eb5983e9
16695120190ANDAAlivio Medical Products, Llc2015-10-01NAPROXENORALTABLETANDA075927cbd9ff1d-ad79-4f44-9db8-4796016bb967

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009045537ANDAMajor2009-11-20NAPROXENORALTABLETANDA074410907ba0f9-e4c9-49d4-9ff8-019739076324
2551540727ANDACardinal Health2009-11-20NAPROXENORALTABLET009045537ANDA074410bd03ffa0-02a7-4b66-82f2-d080562d9f1c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001791978ANDAKaiser Foundations Hospitals2008-10-20NAPROXENORALTABLET684620190ANDA078250c8c7e092-0eb4-4945-934d-0b4cf664ad23
2004401852ANDALiberty Pharmaceuticals, Inc.2010-02-18NAPROXENORALTABLET537460190ANDA0759277466d0fe-819b-4634-a29f-bd838edc3971
3004407852ANDALiberty Pharmaceuticals, Inc.2010-02-18NAPROXENORALTABLET537460190ANDA0759274054e004-de40-4e51-bd37-ce9d04eef164
4006153563ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-12-13NAPROXENORALTABLET000930149ANDA074201e231b3d8-d665-41f1-b8af-d9a71bda09f2
5006157709ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2011-07-18NAPROXENORALTABLET000930149ANDA0742018a2d541e-dfa2-4b37-9b18-ed72c7e4aafb
6006157892ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs2010-02-18NAPROXENORALTABLET537460190ANDA07592787efff5b-8bbf-4039-8b0a-06a1a4dbe9c2
7009046297ANDAMajor2011-02-28NAPROXENORALTABLET250000140ANDA09141627540e0b-d8bd-4409-9e60-f44c55f5acb2
8105440010ANDABlenheim Pharmacal, Inc.2010-08-19NAPROXENORALTABLET000930149ANDA074201fa5cce05-9850-48ef-8a8b-14a11ccc385a
9105440016ANDABlenheim Pharmacal, Inc.2010-09-15NAPROXENORALTABLET537460190ANDA075927942c2438-9fe9-4f31-9617-3c6d029154d3
10105440044ANDABlenheim Pharmacal, Inc.2011-05-04NAPROXENORALTABLET537460190ANDA075927f4d9bd36-b960-47f6-afde-22f5012d419b
11105440061ANDABlenheim Pharmacal, Inc.2012-02-15NAPROXENORALTABLET001431348ANDA076494112fdec3-882b-14df-e054-00144ff88e88
12105440111ANDABlenheim Pharmacal, Inc.2013-03-28NAPROXENORALTABLET526050140ANDA0914169fa8d2d8-30f6-4262-94c3-e8d4d3b04068
13105440278ANDABlenheim Pharmacal, Inc.2010-03-17NAPROXENORALTABLET684620190ANDA07825050954ade-19ad-40dd-8e06-0b33394895f7
14105440922ANDABlenheim Pharmacal, Inc.2015-05-27NAPROXENORALTABLET537460190ANDA07592717139481-c7ac-6162-e054-00144ff8d46c
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16165900163ANDAStat Rx Usa Llc2011-07-18NAPROXENORALTABLET000930149ANDA074201adb7d29b-6341-4290-91a1-2a9ee03273c3
17216950086ANDARebel Distributors Corp2010-02-18NAPROXENORALTABLET537460190ANDA0759278c7b265e-7500-464a-854e-9c4a22c8d211
18242360097ANDARemedyrepack Inc.2013-03-01NAPROXENORALTABLET000930149ANDA074201d185e0dc-fcd5-4081-bad7-9d5a6a0764af
19242360995ANDARemedyrepack Inc.2012-01-12, 2013-07-12, 2013-07-15, 2013-07-25, 2013-10-11, 2015-03-06NAPROXENORALTABLET537460190ANDA075927, ANDA0782506c9ef53b-b65f-4ba6-b1b0-43e12e0d9b3d, 705f45f0-0be4-45f6-8268-3db0c8e8950a, 7ac0a961-1656-48eb-9d03-7697003e319d, 9d2ca251-59d5-4b84-8fa7-1a7dbef4bfc1, a18a2b4c-4eee-40ef-a52b-bf52748550f8, a74280e9-34f9-40ae-9641-5a6802524902, fb9eaf7c-59c7-4c99-8886-eb48a51ea3c4
20332610081ANDAAidarex Pharmaceuticals Llc2010-02-18NAPROXENORALTABLET537460190ANDA075927f23569ab-d9ac-45e8-b8f3-8d0ba612fc2d
21353560682ANDALake Erie Medical Dba Quality Care Products Llc2010-02-18NAPROXENORALTABLET537460190ANDA075927edc20989-53f6-448d-97a4-b2f927eb68d4
22353560683ANDALake Erie Medical Dba Quality Care Products Llc2007-07-01NAPROXENORALTABLET684620190ANDA0782506fa0d207-561e-4f5c-995b-5b1ae3329b7c
23422910628ANDAAvkare, Inc.2013-09-26NAPROXENORALTABLET537460190ANDA075927e94a767d-2db2-f2f3-778e-89d9b049fcaf
24425490592ANDAStat Rx Usa Llc2007-07-01NAPROXENORALTABLET684620190ANDA078250a671b0fb-6b6b-43e7-994b-5de54582c4a7
25430630344ANDAPd-Rx Pharmaceuticals, Inc.2010-02-18NAPROXENORALTABLET537460190ANDA075927ff1bc6ad-ec7a-4128-9510-3ec1546ad43b
26433530677ANDAAphena Pharma Solutions - Tennessee, Llc2004-04-01NAPROXENORALTABLET009045591ANDA076494502f390d-d69e-4a77-8a59-4eedf91004f3
27493490341ANDARemedyrepack Inc.2011-06-28NAPROXENORALTABLET684620190ANDA078250c4b45105-6b8a-45f7-bf50-9fc83b84d048
28493490712ANDARemedyrepack Inc.2011-08-30, 2012-09-04, 2013-07-30NAPROXENORALTABLET537460190ANDA075927347117d8-19ec-4bf1-a0ae-89c98a5049fc, 35f9e465-76c0-435c-9e81-8fd9bb16cedf, 6e243d4d-c2b6-433a-a4d0-608ca0ec4bfb
29499990009ANDALake Erie Medical Dba Quality Care Products Llc2010-09-28NAPROXENORALTABLET001431348ANDA076494434f601e-cc7f-4b1e-a9df-429d61f32350
30502680596ANDAAvpak2015-02-05NAPROXENORALTABLET537460190ANDA075927e6fbf8f1-b064-658d-17bb-e7d6320aa45f
31504366609ANDAUnit Dose Services2010-02-18NAPROXENORALTABLET537460190ANDA0759270fd4b067-560b-4425-bd9b-9f27f31e0a43
32516550626ANDANorthwind Pharmaceuticals, Llc2014-05-28NAPROXENORALTABLET684620190ANDA078250d90378ef-c513-4471-a132-49720ac5d3a3
33521250250ANDARemedyrepack Inc.2013-06-04NAPROXENORALTABLET428060126ANDA091416a26f00f2-55a1-4889-8485-d3f8c401153e
34521250559ANDARemedyrepack Inc.2013-07-01, 2013-07-08, 2013-12-05NAPROXENORALTABLET526050140ANDA091416483fdced-9390-4481-b425-76e441c93006, 8bf04c76-2392-4f99-9ebc-446217758647, d96b6134-06b4-497d-8620-530a97130528, f0aa635b-95d6-4ee8-bbe5-789069b7aca3
35521250580ANDARemedyrepack Inc.2013-06-24, 2013-07-08, 2014-02-20, 2014-04-16NAPROXENORALTABLET526050140ANDA09141640d89dd5-efb5-4a93-b657-bbde8fa74c8b, 9e0e24a1-0e39-4126-8916-8f930684d5e0, cbe06d60-ce7b-4b16-b0d4-1f7ba084d2ac, e454fc0c-bc27-4ff3-af6d-55ccb4b629ba
36521250794ANDARemedyrepack Inc.2013-12-05NAPROXENORALTABLET000930149ANDA074201ef9044c1-eed3-4239-8f8b-64affd7a9ba0
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38538081053ANDAState Of Florida Doh Central Pharmacy2014-01-01NAPROXENORALTABLET317220342ANDA091305fed6b90f-9a64-49ee-aab8-3936f5435856
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40551544997ANDACardinal Health2013-09-30NAPROXENORALTABLET680840127ANDA09130541c455e5-c24d-4fd5-b6b3-024b8ea8af92
41551548273ANDACardinal Health2010-12-13NAPROXENORALTABLET000930149ANDA074201d895f039-acf5-4fac-9698-11b8bac45159
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47619190163ANDADirect Rx2014-01-01NAPROXENORALTABLET537460190ANDA075927686df0dd-42ac-4cd7-b838-51b172b06e0b
48619190586ANDADirect Rx2015-01-01NAPROXENORALTABLET317220342ANDA09130550c696da-0ea6-4d76-b50e-fb0b55ff77ae
49631870028ANDAProficient Rx Lp2007-07-01NAPROXENORALTABLET684620190ANDA07825096601d76-50ea-4dc0-b588-d174f8d8bb51
50631870455ANDAProficient Rx Lp2010-02-18NAPROXENORALTABLET537460190ANDA075927fc3ee94a-adb7-411e-a662-2f2c6ddbabaf
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53638740326ANDAAltura Pharmaceuticals, Inc.2010-01-01NAPROXENORALTABLET684620190ANDA0782504bbe6e74-b13e-4609-b4cc-aa0b00d66df8
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56675440475ANDAAphena Pharma Solutions - Tennessee, Inc.2010-02-18NAPROXENORALTABLET537460190ANDA07592792c48cd9-e645-4871-a0ad-9ea56623edb6
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58683870800ANDAKeltman Pharmaceuticals Inc.2009-04-27NAPROXENORALTABLET537460190ANDA0759271a10952e-0662-4f2c-bd02-28dd4eee138f
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naproxen sodium 220 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002800270MenstridolNDABayer Healthcare Llc2014-07-01NAPROXEN SODIUMORALTABLETNDA020204a88ec30b-24df-4fca-ad16-aea8ff296906
2002806010AleveNDABayer Healthcare Llc2002-07-26NAPROXEN SODIUMORALTABLETNDA02020400ef5b30-71d0-4cb4-84a3-48c67d1cea2a
3002806020AleveNDABayer Healthcare Llc2002-08-01NAPROXEN SODIUMORALTABLET, COATEDNDA0202040ad8bbb9-dd5f-4273-b085-ee3e5ed22613
4002806060AleveNDABayer Healthcare Llc2002-07-26NAPROXEN SODIUMORALTABLETNDA0202043c0ddd25-5a9a-4628-a971-65fe2a9775b5
5533290675NDAMedline Industries, Inc.2002-07-26NAPROXEN SODIUMORALTABLETNDA0202041ffd186b-7380-4e17-919e-2352d112bd30
6667159702AleveNDALil' Drug Store Products, Inc2000-01-01NAPROXEN SODIUMORALTABLETNDA020204abfcf13e-6eba-49e2-8ebf-459348714270

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001130368ANDAL. Perrigo Company1997-01-14NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661b8356697-41a0-48cd-b0c4-327bcdf534ca
2001130901ANDAL. Perrigo Company2014-04-23NAPROXEN SODIUMORALTABLETANDA0746616bc74cda-458c-480e-a33c-d2ba68d5e6bd
3001134368ANDAL. Perrigo Company2014-03-31NAPROXEN SODIUMORALTABLET, FILM COATEDANDA0746618e150c00-8e5b-40b4-a964-cb70442c2752
4001139490ANDAL. Perrigo Company1997-01-14NAPROXEN SODIUMORALTABLETANDA074661f587cc15-3db3-449a-b36c-5720a8475ab2
5003630140ANDAWalgreens2011-10-22NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661e8f3d7e8-cd29-4536-86b7-44c3d5f08ba6
6003630168ANDAWalgreens2014-03-31NAPROXEN SODIUMORALTABLETANDA07909601a13827-8256-49c3-9721-8cdad491a641
7003630169ANDAWalgreens2014-03-31NAPROXEN SODIUMORALTABLETANDA07909664f8e05a-690c-4bb0-b41a-bae37b91a6e0
8003630368ANDAWalgreens1997-01-14NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661318d4e2a-7108-4e88-8e56-5bec17ca4a3e
9003630490ANDAWalgreens1997-01-14NAPROXEN SODIUMORALTABLETANDA074661d2858775-de6a-4e14-b100-294ec9b074d4
10003630938ANDAWalgreens2014-07-31NAPROXEN SODIUMORALTABLETANDA0746618ea540bf-4958-41f9-980f-5936c074a51d
11005361022ANDARugby Laboratories2014-03-10NAPROXEN SODIUMORALTABLETANDA09054505cf0ab1-293c-4740-84b8-9a4a1cc3e9d9
12005361023ANDARugby Laboratories2014-03-10NAPROXEN SODIUMORALTABLETANDA09054505cf0ab1-293c-4740-84b8-9a4a1cc3e9d9
13005361093ANDARugby Laboratories2015-09-02NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07466116e107f0-45a3-428f-b849-0f20a848a602
14005361094ANDARugby Laboratories2015-09-02NAPROXEN SODIUMORALTABLETANDA074661f587a428-291c-4c54-80fe-244a961b0521
15009045229ANDAMajor1997-01-09NAPROXEN SODIUMORALTABLETANDA074661019a655e-0256-4de4-b587-50f463e812b9
16009045230ANDAMajor1997-01-09NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661495e86b9-ddd5-42b2-a335-0154fd461b6b
17100560368ANDAAccess Business Group Llc2009-09-29NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07466107ce84c8-324c-4fc9-a8cc-14259d9a42a8
18100560400ANDAAccess Business Group Llc2000-07-06NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07466154af4cbc-e49f-4c73-852e-d406ff2cb602
19102020368ANDA7-Eleven2014-08-05NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661b5f35332-2548-44a4-8d5c-9bbb1b3218ca
20102020490ANDA7-Eleven2014-08-11NAPROXEN SODIUMORALTABLETANDA074661c76c983e-d680-4908-b79d-968a2e4b1246
21116730368ANDATarget Corp2009-06-24NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07466100bd8490-f280-4336-b13d-0e11c0bf4586
22116730490ANDATarget Corp2009-07-14NAPROXEN SODIUMORALTABLETANDA07466125640871-e99b-4e46-8bdc-698b574e6391
23118220368ANDARite Aid2001-05-16NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661998a8214-1def-4e35-8339-c631d604dedf
24118220490ANDARite Aid2001-05-16NAPROXEN SODIUMORALTABLETANDA0746611b63177f-17e5-4b5a-8924-7023efe016aa
25118220507ANDARite Aid2001-05-16NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661af07cecf-e8f5-4f76-9df7-e634256f332f
26211300016ANDABetter Living Brands Llc2015-10-24NAPROXEN SODIUMORALTABLETANDA0746613e7ff599-7504-4277-9970-f64ebef47bc7
27211300140ANDABetter Living Brands Llc2008-10-03NAPROXEN SODIUMORALTABLET, FILM COATEDANDA0746612ddcffad-7dad-47ae-ba2e-6abee8ea38bd
28211300300ANDABetter Living Brands Llc2015-03-02NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661f945d1f2-77d9-4726-b999-ae8ddb8ac7e4
29211300368ANDABetter Living Brands Llc2007-09-12NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07466101fc237c-f801-4ebe-a898-0bca12a7c7a8
30211300444ANDABetter Living Brands Llc2015-09-04NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661a970d373-c0e1-4d56-8379-6bb3a009ac76
31211300507ANDABetter Living Brands Llc2015-09-29NAPROXEN SODIUMORALTABLET, FILM COATEDANDA0746616bb5a659-1588-4d0c-ad0a-588aec8c8714
32243850368ANDAGood Neighbor Pharmacy1997-01-15NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661f09b98f3-fb36-436a-9a8a-828a5d897c01
33243850490ANDAGood Neighbor Pharmacy1998-03-12NAPROXEN SODIUMORALTABLETANDA0746614a16e30c-ff99-40c2-8bba-73be48bdf61d
34250000141ANDAMarksans Pharma Limited2011-05-28NAPROXEN SODIUMORALTABLETANDA09054548cb1363-ff12-40ee-a87a-2252dfbf8ff7
35250000144ANDAMarksans Pharma Limited2011-05-04NAPROXEN SODIUMORALTABLETANDA09054548cb1363-ff12-40ee-a87a-2252dfbf8ff7
36278540103ANDABelmora Llc2012-12-06NAPROXEN SODIUMORALTABLETANDA079096d5d50bad-9fb2-4575-8ce2-dc8c11c621a2
37301420055ANDAKroger2014-11-09NAPROXEN SODIUMORALTABLETANDA091353a7d0bd27-3706-4086-8ab4-0fea01e6de62
38301420168ANDAKroger2011-02-02NAPROXEN SODIUMORALTABLETANDA079096e53453fa-6c7a-4826-b317-617c56f91890
39301420177ANDAKroger2005-02-08NAPROXEN SODIUMORALTABLET, FILM COATEDANDA0746614d4f87aa-5189-4037-9c00-d870de81d4dc
40301420368ANDAKroger1997-01-16NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661bf84e579-1cb0-4be1-b1f0-41875808349c
41301420490ANDAKroger2004-05-10NAPROXEN SODIUMORALTABLETANDA074661f245f5a6-88b6-4bb4-91f1-b4a91eaac3b3
42301420500ANDAKroger2014-03-06NAPROXEN SODIUMORALTABLETANDA074661776899ea-0b82-44c7-b277-f3fc2b5f2b6d
43301420617ANDAKroger1997-01-16NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07466102f012e3-8278-4a8b-9cdf-6d14843c8a78
44301420980ANDAKroger2005-02-08NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661479d69a9-ad96-4190-b196-5a7ec85a0485
45354180000ANDAZee Medical Inc2015-03-31NAPROXEN SODIUMORALTABLETANDA090545eddc0d8b-154a-43a3-8ade-6c746f21ba81
46368000055ANDATop Care (Topco Associates Llc)2014-06-30NAPROXEN SODIUMORALTABLETANDA091353ff5c3525-6389-4bfa-8092-d8d91a54ab50
47368000140ANDATop Care (Topco Associates Llc)2007-12-03NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661f151d48d-a8f7-484e-9ce8-6b2e8dd1093f
48368000256ANDATop Care (Topco Associates Llc)2014-06-30NAPROXEN SODIUMORALTABLETANDA0913538837e1eb-1a79-4078-9eef-39295bcc9773
49368000368ANDATop Care (Topco Associates Llc)1997-01-14NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661079eccdd-33bd-4b5c-bf46-9aef78559082
50368000490ANDATop Care (Topco Associates Llc)1997-01-14NAPROXEN SODIUMORALTABLETANDA0746617f1cda40-9a67-4de1-af56-ab881c6354c4
51370120368ANDAShopko Stores Operating Co, Llc2014-05-19NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661b088dbc5-483c-45f9-9876-378d8843efff
52372050261ANDACardinal Health2001-09-26NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661d006a8eb-1cfb-4f88-a498-6fad49033c31
53372050262ANDACardinal Health2012-06-25NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07909605a2e1a7-6c3b-48d3-99e1-f18f6b1ee25e
54372050744ANDACardinal Health2012-08-30NAPROXEN SODIUMORALTABLETANDA079096d7fa3702-33c5-4dc9-a2e4-2d3a9a6d1392
55378080068ANDAH-E-B2015-09-30NAPROXEN SODIUMORALTABLETANDA0790966dd54a14-67cd-4295-9bd5-1d6f8cb9316d
56378080140Rx-Act All Day Pain ReliefANDAH-E-B2008-02-12NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661422fff1d-8c2b-4829-a772-e3fef3b42694
57378080259ANDAH-E-B1997-02-24NAPROXEN SODIUMORALTABLETANDA07466173745306-18b8-4ba1-af73-d28fc3fbbf08
58378080339ANDAH-E-B2008-02-12NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661d8d56dc6-c0c2-49fd-ac16-4cecf7d3cb5d
59378080368Rx-Act All Day Pain ReliefANDAH-E-B2009-02-12NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661df6fbdff-f101-4780-8ea5-95c1ac7222a4
60378080490Rx-Act All Day Pain ReliefANDAH-E-B1997-02-24NAPROXEN SODIUMORALTABLETANDA07466199dce506-c2c4-4a0a-b07c-d599f68c13ca
61378080500ANDAH-E-B1997-02-24NAPROXEN SODIUMORALTABLET, FILM COATEDANDA0746616402a5b3-3e29-47aa-a37c-0c54605347c7
62411630140ANDASupervalu, Inc2005-02-08NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661d7aa549c-4055-4368-b4ed-c5d05ae10108
63411630167ANDASupervalu, Inc2013-05-09NAPROXEN SODIUMORALTABLETANDA079096b21ab16b-6e03-4efa-8b94-13a3c1792ccb
64411630169ANDASupervalu, Inc2010-11-15NAPROXEN SODIUMORALTABLETANDA079096a29dad63-d042-4b34-8809-f2419483139f
65411630323ANDASupervalu, Inc2014-07-14NAPROXEN SODIUMORALTABLET, FILM COATEDANDA0746612bfe5eb6-04c5-4575-9192-a0be335b7097
66411630368ANDASupervalu, Inc2004-08-10NAPROXEN SODIUMORALTABLET, FILM COATEDANDA074661c865bd73-eb89-4d25-b88c-214867c8f715
67411630490ANDASupervalu, Inc2004-08-10NAPROXEN SODIUMORALTABLETANDA074661961219ab-6bab-443a-bf9e-4c68186362b3
68411630511ANDASupervalu, Inc2014-09-24NAPROXEN SODIUMORALTABLET, FILM COATEDANDA0746611022d075-9bdf-46df-81ac-c84cb2608195
69411630707ANDASupervalu, Inc2014-09-24NAPROXEN SODIUMORALTABLETANDA07466189c02e55-fa08-4001-96fc-8a01e7e74d5a
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relabeler product(s)(s)

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2216950088ANDARebel Distributors Corp1998-03-12NAPROXEN SODIUMORALTABLET243850490ANDA074661456815fd-1e98-43fa-8f20-47cc3b8a15bd
3332610079ANDAAidarex Pharmaceuticals Llc1997-01-14NAPROXEN SODIUMORALTABLET001139490ANDA07466163fd9a6a-cae5-4f3e-b14a-acd4c66c0852
4422540230ANDARebel Distributors Corp1997-01-14NAPROXEN SODIUMORALTABLET001139490ANDA074661c863fdd7-5919-4ee0-b2d1-952c5faf3a09
5499990068ANDALake Erie Medical Dba Quality Care Products Llc1997-01-09NAPROXEN SODIUMORALTABLET009045229ANDA074661fd09dd9e-88dc-4c2f-856f-a91f1ac041b2
6502690201AleveNDAJc World Bell Wholesale Co., Inc.2014-07-14NAPROXEN SODIUMORALTABLET002806000NDA020204f753a557-6a26-4b5b-bb1e-d9f2b621b846
7504366606ANDAUnit Dose Services1997-01-14NAPROXEN SODIUMORALTABLET001139490ANDA0746612fcfadfa-4222-40c7-8c3b-ff188ae33026
8516550624ANDANorthwind Pharmaceuticals, Llc2014-07-14NAPROXEN SODIUMORALTABLET458020490ANDA074661027c59ed-3441-44ad-a42a-2f8efec052af
9529590469ANDAH.J. Harkins Company, Inc.1997-01-09NAPROXEN SODIUMORALTABLET009045229ANDA074661bc79612a-1db4-457f-8e15-0c7659c34c2a
10533290671ANDAMedline Industries, Inc.2013-04-30NAPROXEN SODIUMORALTABLET537460191ANDA0790966182a3ed-17d6-4fb2-a421-42c95eac7dd7
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naproxen sodium 275 mg oral tablet

original product(s)(s)

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1000046202AnaproxNDAGenentech, Inc.1980-09-04NAPROXEN SODIUMORALTABLETNDA01816468848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

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3537460193ANDAAmneal Pharmaceuticals, Llc2007-04-26NAPROXEN SODIUMORALTABLETANDA0784323c55594c-7801-4f59-8f4f-e85a03f3776b
4591150002ANDAHikma Pharmaceutical1998-02-18NAPROXEN SODIUMORALTABLETANDA0744806782632c-c8a0-4cab-89af-9d1c5f392c8f
5651620193ANDAAmneal Pharmaceuticals2007-04-26NAPROXEN SODIUMORALTABLETANDA0784328723365e-b06a-4bcc-bec1-1902a9e5db5e
6658620515ANDAAurobindo Pharma Limited2011-10-31NAPROXEN SODIUMORALTABLET, FILM COATEDANDA20062937b264f9-b46d-4635-8fab-246b1e08b653
7684620178ANDAGlenmark Generics Inc., Usa2007-08-01NAPROXEN SODIUMORALTABLETANDA0783146c5bb008-e66f-4ef0-bf84-aca7eb5983e9

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046185ANDAMajor2007-04-26NAPROXEN SODIUMORALTABLET537460193ANDA078432add6d613-6895-48fd-97b2-259df3cde8d2
2105440063ANDABlenheim Pharmacal, Inc.2012-01-12NAPROXEN SODIUMORALTABLET684620178ANDA078314d32e840b-c984-4f74-8c0c-ad44fa7a4f36
3105440128ANDABlenheim Pharmacal, Inc.2013-08-26NAPROXEN SODIUMORALTABLET537460193ANDA078432117b20fa-6ccc-5852-e054-00144ff88e88
4105440275ANDABlenheim Pharmacal, Inc.2010-03-22NAPROXEN SODIUMORALTABLET684620178ANDA07831450954ade-19ad-40dd-8e06-0b33394895f7
5332610084ANDAAidarex Pharmaceuticals Llc2007-04-26NAPROXEN SODIUMORALTABLET537460193ANDA07843230cc16cd-720d-4baa-8941-bfdc28b62b04
6422910531ANDAAvkare, Inc.2007-04-26NAPROXEN SODIUMORALTABLET537460193ANDA07843269c31552-4568-4880-927c-0399494f6fa1
7430630462ANDAPd-Rx Pharmaceuticals, Inc.1993-12-22NAPROXEN SODIUMORALTABLET, FILM COATED000930536ANDA07419830a3ff24-a7aa-48bb-9d60-73aad2e48e08
8458650519ANDAMedsource Pharmaceuticals2007-08-01NAPROXEN SODIUMORALTABLET684620178ANDA0783141ea7e83b-e28b-17f7-e054-00144ff8d46c
9502680592ANDAAvpak2012-10-11NAPROXEN SODIUMORALTABLET537460193ANDA0784329316bbe0-a194-d2a8-8f86-6d39e4d8f20e
10548683359ANDAPhysicians Total Care, Inc.1994-12-052011-06-30NAPROXEN SODIUMORALTABLET684620178ANDA078314577b9f26-ab59-4b15-a26a-465f0d255bad
11552890467ANDAPd-Rx Pharmaceuticals, Inc.2007-08-01NAPROXEN SODIUMORALTABLET684620178ANDA07831449a3fccf-6592-48c6-9b69-33230182457c
12636293638ANDABryant Ranch Prepack2007-08-01NAPROXEN SODIUMORALTABLET684620178ANDA078314332c4d37-04d0-ed7a-949f-df7cf4efb12e
13638740489ANDAAltura Pharmaceuticals, Inc.2010-01-01NAPROXEN SODIUMORALTABLET684620178ANDA0783144bbe6e74-b13e-4609-b4cc-aa0b00d66df8

naproxen sodium 550 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000046203AnaproxNDAGenentech, Inc.1980-09-04NAPROXEN SODIUMORALTABLETNDA01816468848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930537ANDATeva Pharmaceuticals Usa Inc1993-12-22NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07419862045862-c90d-4545-9494-af32a65cf689
2001439908ANDAWest-Ward Pharmaceutical Corp1996-05-14NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07448021f1d859-e73d-4411-b35d-53a281d09177
3537460194ANDAAmneal Pharmaceuticals, Llc2007-04-26NAPROXEN SODIUMORALTABLETANDA0784323c55594c-7801-4f59-8f4f-e85a03f3776b
4585170300ANDANew Horizon Rx Group, Llc2013-08-25NAPROXEN SODIUMORALTABLET, FILM COATEDANDA07843221e6c0e1-10e8-4f0f-907d-3a514f7299fc
5651620194ANDAAmneal Pharmaceuticals2007-04-26NAPROXEN SODIUMORALTABLETANDA0784328723365e-b06a-4bcc-bec1-1902a9e5db5e
6658620516ANDAAurobindo Pharma Limited2011-10-31NAPROXEN SODIUMORALTABLET, FILM COATEDANDA20062937b264f9-b46d-4635-8fab-246b1e08b653
7684620179ANDAGlenmark Generics Inc., Usa2007-08-01NAPROXEN SODIUMORALTABLETANDA0783146c5bb008-e66f-4ef0-bf84-aca7eb5983e9

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1009046186ANDAMajor2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA078432add6d613-6895-48fd-97b2-259df3cde8d2
2105440276ANDABlenheim Pharmacal, Inc.2010-03-17NAPROXEN SODIUMORALTABLET684620179ANDA07831450954ade-19ad-40dd-8e06-0b33394895f7
3105440614ANDABlenheim Pharmacal, Inc.2010-05-17NAPROXEN SODIUMORALTABLET, FILM COATED001439908ANDA07448011b938f8-f1de-4d63-e054-00144ff88e88
4165900165ANDAStat Rx Usa Llc1998-02-18NAPROXEN SODIUMORALTABLET001439908ANDA074480926971f1-dcff-4e9e-9ee3-35eb22402716
5178560194ANDAAtlantic Biologicals Corps2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA07843282e83f79-3717-4469-8bc8-aea07a7f62b9
6216950090ANDARebel Distributors Corp2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA0784320c01cb34-0d6b-4248-afde-82d4d934dabd
7332610085ANDAAidarex Pharmaceuticals Llc2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA07843230cc16cd-720d-4baa-8941-bfdc28b62b04
8333580259ANDARxchange Co.2014-11-11NAPROXEN SODIUMORALTABLET537460194ANDA078432ab88c208-6178-41cf-a6f1-88063e340f39
9353560748ANDALake Erie Medical Dba Quality Care Products Llc2010-11-01NAPROXEN SODIUMORALTABLET, FILM COATED000930537ANDA074198b212412f-8a35-40d8-b553-5b71ff3881f5
10422910532ANDAAvkare, Inc.2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA07843269c31552-4568-4880-927c-0399494f6fa1
11425490566ANDAStat Rx Usa Llc2007-08-01NAPROXEN SODIUMORALTABLET684620179ANDA078314a671b0fb-6b6b-43e7-994b-5de54582c4a7
12493490300ANDARemedyrepack Inc.2011-06-09NAPROXEN SODIUMORALTABLET001439908ANDA07448021f82a95-c283-4c18-b47d-f6ba26e34299
13493490604ANDARemedyrepack Inc.2011-11-03, 2014-11-12NAPROXEN SODIUMORALTABLET537460194ANDA07843249dad331-1d5a-49f0-bbd2-8c1801c490cf, 907fce46-6f0f-4752-b9d3-838ae113f788
14499990058ANDALake Erie Medical Dba Quality Care Products Llc1996-05-14NAPROXEN SODIUMORALTABLET, FILM COATED001439908ANDA0744805efc62b9-9de1-4bb4-a2d4-fa3393f87736
15502680593ANDAAvpak2012-10-11NAPROXEN SODIUMORALTABLET537460194ANDA0784329316bbe0-a194-d2a8-8f86-6d39e4d8f20e
16504366613ANDAUnit Dose Services2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA078432d76607a3-c2c3-4b49-8c08-eba84494feb9
17516550627ANDANorthwind Pharmaceuticals, Llc2014-08-07NAPROXEN SODIUMORALTABLET537460194ANDA07843200a746cd-5c7e-4b41-b4ac-3cfec36a5e2d
18521250628ANDARemedyrepack Inc.2013-08-23, 2014-07-10NAPROXEN SODIUMORALTABLET537460194ANDA07843274dc8216-611c-4ca6-b24a-ed81892ba6f7, be38254f-40a5-48b3-9194-77d30eaea371
19529590271ANDAH.J. Harkins Company, Inc.2007-07-01NAPROXEN SODIUMORALTABLET684620179ANDA07825096ef2f48-d478-478c-95d0-1c0b986493d1
20538080742ANDAState Of Florida Doh Central Pharmacy2009-07-01NAPROXEN SODIUMORALTABLET, FILM COATED000930537ANDA0742015d85fd0c-c544-4026-b797-93445ce6ba7e
21538080872ANDAState Of Florida Doh Central Pharmacy2013-01-01NAPROXEN SODIUMORALTABLET537460194ANDA078432b91552c0-7de3-4a7a-902b-691eb7ca518b
22548683043ANDAPhysicians Total Care, Inc.1994-01-14NAPROXEN SODIUMORALTABLET684620179ANDA078314577b9f26-ab59-4b15-a26a-465f0d255bad
23552890367ANDAPd-Rx Pharmaceuticals, Inc.2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA07843258caec51-74aa-44b8-9638-f7cca096a54a
24581180194ANDAClinical Solutions Wholesale2010-02-18NAPROXENORALTABLET537460194ANDA0759278554e4e0-8ded-44d7-a7f7-bb45d5e45858
25631870121ANDAProficient Rx Lp2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA078432da9b993d-3eb5-4b11-a292-62e378d70fb2
26636291260ANDABryant Ranch Prepack2007-04-26, 2009-07-30NAPROXEN SODIUMORALTABLET537460194ANDA0784329244e41c-94c9-428b-a254-703b71f9460b, 9e20e097-0b98-ccd3-bef4-68fb694de77d
27638740339ANDAAltura Pharmaceuticals, Inc.2010-01-01NAPROXEN SODIUMORALTABLET684620179ANDA0783144bbe6e74-b13e-4609-b4cc-aa0b00d66df8
28683870545ANDAKeltman Pharmaceuticals Inc.2010-12-10NAPROXEN SODIUMORALTABLET537460194ANDA0784320fc2f04c-43a0-4831-b499-369f06a4106a
29687889022ANDAPreferred Pharmaceuticals, Inc.2007-04-26NAPROXEN SODIUMORALTABLET537460194ANDA078432c469dded-01b1-46ed-bd20-e5a4eca7a938

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074105NAPROXENTrueDAVA PHARMACEUTICALS INC1993-12-21ANDA074105_001, ANDA074105_002, ANDA074105_003
2ANDA074106NAPROXEN SODIUMTrueHAMILTON PHARMACEUTICALS LTD1993-08-31ANDA074106_001, ANDA074106_002Naproxen Oral Capsule
3ANDA074110NAPROXENTrueHAMILTON PHARMACEUTICALS LTD1992-10-30ANDA074110_001, ANDA074110_002, ANDA074110_003
4ANDA074111NAPROXENTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-02-28ANDA074111_001, ANDA074111_002, ANDA074111_003
5ANDA074121NAPROXENMYLAN PHARMACEUTICALS INC1993-12-21ANDA074121_001, ANDA074121_002, ANDA074121_003
6ANDA074129NAPROXENTrueTEVA PHARMACEUTICALS USA INC1993-12-21ANDA074129_001, ANDA074129_002, ANDA074129_003
7ANDA074140NAPROXENSANDOZ INC1993-12-21ANDA074140_001, ANDA074140_002, ANDA074140_003
8ANDA074142NAPROXEN SODIUMTrueTEVA PHARMACEUTICALS USA INC1993-12-21ANDA074142_001, ANDA074142_002Naproxen Oral Capsule
9ANDA074162NAPROXEN SODIUMTrueSANDOZ INC1993-12-21ANDA074162_001, ANDA074162_002Naproxen Oral Capsule
10ANDA074163NAPROXENTrueWATSON LABORATORIES INC1995-02-10ANDA074163_001, ANDA074163_002, ANDA074163_003
11ANDA074182NAPROXENTruePLIVA INC1996-06-27ANDA074182_001, ANDA074182_002, ANDA074182_003
12ANDA074195NAPROXEN SODIUMTrueWATSON LABORATORIES INC1993-12-21ANDA074195_001, ANDA074195_002Naproxen Oral Capsule
13ANDA074198NAPROXEN SODIUMTEVA PHARMACEUTICALS USA INC1993-12-21ANDA074198_001, ANDA074198_002Naproxen Oral Capsule
14ANDA074201NAPROXENTEVA PHARMACEUTICALS USA INC1993-12-21ANDA074201_001, ANDA074201_002, ANDA074201_003
15ANDA074207NAPROXENTrueTEVA PHARMACEUTICALS USA1993-12-21ANDA074207_001, ANDA074207_002, ANDA074207_003
16ANDA074211NAPROXENTrueROXANE LABORATORIES INC1994-02-28ANDA074211_001, ANDA074211_002, ANDA074211_003
17ANDA074216NAPROXENTrueTEVA PHARMACEUTICALS USA INC1996-04-11ANDA074216_001, ANDA074216_002, ANDA074216_003
18ANDA074230NAPROXEN SODIUMTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1995-03-14ANDA074230_001, ANDA074230_002Naproxen Oral Capsule
19ANDA074242NAPROXEN SODIUMTruePLIVA INC1996-06-20ANDA074242_001, ANDA074242_002Naproxen Oral Capsule
20ANDA074257NAPROXEN SODIUMTrueROXANE LABORATORIES INC1993-12-21ANDA074257_001, ANDA074257_002Naproxen Oral Capsule
21ANDA074263NAPROXENTruePUREPAC PHARMACEUTICAL CO1993-12-21ANDA074263_001, ANDA074263_002, ANDA074263_003
22ANDA074289NAPROXEN SODIUMTrueTEVA PHARMACEUTICALS USA1994-01-27ANDA074289_001, ANDA074289_002Naproxen Oral Capsule
23ANDA074319NAPROXEN SODIUMTruePUREPAC PHARMACEUTICAL CO1995-03-20ANDA074319_001, ANDA074319_002Naproxen Oral Capsule
24ANDA074367NAPROXEN SODIUMTrueMYLAN PHARMACEUTICALS INC1994-08-31ANDA074367_001, ANDA074367_002Naproxen Oral Capsule
25ANDA074410NAPROXENTrueDAVA PHARMACEUTICALS INC1995-04-28ANDA074410_001, ANDA074410_002, ANDA074410_003
26ANDA074455NAPROXEN SODIUMTrueWATSON LABORATORIES INC1995-05-31ANDA074455_001, ANDA074455_002Naproxen Oral Capsule
27ANDA074457NAPROXENTrueWATSON LABORATORIES INC1995-05-31ANDA074457_001, ANDA074457_002, ANDA074457_003
28ANDA074480NAPROXEN SODIUMHIKMA PHARMACEUTICALS1996-05-14ANDA074480_001, ANDA074480_002Naproxen Oral Capsule
29ANDA074495NAPROXEN SODIUMTrueSANDOZ INC1994-12-05ANDA074495_001, ANDA074495_002Naproxen Oral Capsule
30ANDA074635NAPROXEN SODIUMCONTRACT PHARMACAL CORP1997-01-13ANDA074635_001Naproxen Oral Capsule
31ANDA074646NAPROXEN SODIUMTrueSANDOZ INC1997-01-13ANDA074646_001Naproxen Oral Capsule
32ANDA074661NAPROXEN SODIUML PERRIGO CO1997-01-13ANDA074661_001Naproxen Oral Capsule
33ANDA074789NAPROXEN SODIUMCONTRACT PHARMACAL CORP1997-02-27ANDA074789_001Naproxen Oral Capsule
34ANDA074936NAPROXENTrueACTAVIS ELIZABETH LLC1998-02-24ANDA074936_001, ANDA074936_002Naproxen Delayed Release Oral Tablet
35ANDA075061NAPROXENSANDOZ INC1998-02-18ANDA075061_001, ANDA075061_002Naproxen Delayed Release Oral Tablet
36ANDA075168NAPROXEN SODIUMDR REDDYS LABORATORIES INC1998-07-28ANDA075168_001Naproxen Oral Capsule
37ANDA075227NAPROXENTEVA PHARMACEUTICALS USA INC1998-06-30ANDA075227_001, ANDA075227_002Naproxen Delayed Release Oral Tablet
38ANDA075337NAPROXENPLIVA INC1999-05-26ANDA075337_001, ANDA075337_002Naproxen Delayed Release Oral Tablet
39ANDA075390NAPROXENMYLAN PHARMACEUTICALS INC2001-04-19ANDA075390_001, ANDA075390_002Naproxen Delayed Release Oral Tablet
40ANDA075927NAPROXENAMNEAL PHARMACEUTICALS NY LLC2001-12-18ANDA075927_001, ANDA075927_002, ANDA075927_003
41ANDA076494NAPROXENHIKMA INTERNATIONAL PHARMACEUTICALS LLC2004-01-14ANDA076494_001, ANDA076494_002, ANDA076494_003
42ANDA076544NAPROXEN SODIUMTrueABLE LABORATORIES INC2003-08-22ANDA076544_001, ANDA076544_002Naproxen Oral Capsule
43ANDA077339NAPROXENPERRIGO R AND D CO2005-04-27ANDA077339_001, ANDA077339_002, ANDA077339_003
44ANDA078250NAPROXENGLENMARK GENERICS LTD2007-03-28ANDA078250_001, ANDA078250_002, ANDA078250_003
45ANDA078314NAPROXEN SODIUMGLENMARK GENERICS LTD2007-04-27ANDA078314_001, ANDA078314_002Naproxen Oral Capsule
46ANDA078432NAPROXEN SODIUMAMNEAL PHARMACEUTICALS NY LLC2007-04-25ANDA078432_001, ANDA078432_002Naproxen Oral Capsule
47ANDA078486NAPROXEN SODIUMDR REDDYS LABORATORIES LTD2007-07-26ANDA078486_001, ANDA078486_002Naproxen Oral Capsule
48ANDA078620NAPROXENZYDUS PHARMACEUTICALS USA INC2007-06-07ANDA078620_001, ANDA078620_002, ANDA078620_003
49ANDA079096NAPROXEN SODIUMAMNEAL PHARMACEUTICALS NY LLC2008-12-16ANDA079096_001Naproxen Oral Capsule
50ANDA090545NAPROXEN SODIUMMARKSANS PHARMA LTD2011-03-16ANDA090545_001Naproxen Oral Capsule
51ANDA091183NAPROXEN SODIUMSUN PHARMACEUTICAL INDUSTRIES LTD2011-05-20ANDA091183_001Naproxen Oral Capsule
52ANDA091305NAPROXENINVAGEN PHARMACEUTICALS INC2011-08-24ANDA091305_001, ANDA091305_002, ANDA091305_003
53ANDA091353NAPROXEN SODIUMGRANULES INDIA LTD2011-09-20ANDA091353_001Naproxen Oral Capsule
54ANDA091416NAPROXENMARKSANS PHARMA LTD2011-02-14ANDA091416_001, ANDA091416_002, ANDA091416_003
55ANDA091432NAPROXENINVAGEN PHARMACEUTICALS INC2011-09-19ANDA091432_001, ANDA091432_002Naproxen Delayed Release Oral Tablet
56ANDA200429NAPROXENAUROBINDO PHARMA USA INC2011-11-08ANDA200429_001, ANDA200429_002, ANDA200429_003
57ANDA200629NAPROXEN SODIUMAUROBINDO PHARMA LTD2011-10-31ANDA200629_001, ANDA200629_002Naproxen Oral Capsule
58NDA017581NAPROSYNROCHE PALO ALTO LLCNDA017581_002, NDA017581_003, NDA017581_004
59NDA018164ANAPROXHOFFMANN LA ROCHE INCNDA018164_001, NDA018164_003Naproxen Oral Capsule
60NDA020067EC-NAPROSYNROCHE PALO ALTO LLC1994-10-14NDA020067_002, NDA020067_003Naproxen Delayed Release Oral Tablet
61NDA020204ALEVEBAYER HEALTHCARE LLC1994-01-11NDA020204_002Naproxen Oral Capsule

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074105_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1993-12-21NAPROXEN
2ANDA074105_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1993-12-21NAPROXEN
3ANDA074105_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1993-12-21NAPROXEN
4ANDA074106_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1993-08-31NAPROXEN SODIUM
5ANDA074106_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1993-08-31NAPROXEN SODIUM
6ANDA074110_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1992-10-30NAPROXEN
7ANDA074110_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1992-10-30NAPROXEN
8ANDA074110_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1992-10-30NAPROXEN
9ANDA074111_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1995-02-28NAPROXEN
10ANDA074111_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1995-02-28NAPROXEN
11ANDA074111_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1995-02-28NAPROXEN
12ANDA074121_001RXNAPROXEN (250MG)ORALTABLETFalseAB1993-12-21NAPROXEN
13ANDA074121_002RXNAPROXEN (375MG)ORALTABLETFalseAB1993-12-21NAPROXEN
14ANDA074121_003RXNAPROXEN (500MG)ORALTABLETFalseAB1993-12-21NAPROXEN
15ANDA074129_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1993-12-21NAPROXEN
16ANDA074129_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1993-12-21NAPROXEN
17ANDA074129_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1993-12-21NAPROXEN
18ANDA074140_001RXNAPROXEN (250MG)ORALTABLETFalseAB1993-12-21NAPROXEN
19ANDA074140_002RXNAPROXEN (375MG)ORALTABLETFalseAB1993-12-21NAPROXEN
20ANDA074140_003RXNAPROXEN (500MG)ORALTABLETFalseAB1993-12-21NAPROXEN
21ANDA074142_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
22ANDA074142_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
23ANDA074162_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
24ANDA074162_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
25ANDA074163_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1995-02-10NAPROXEN
26ANDA074163_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1995-02-10NAPROXEN
27ANDA074163_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1995-02-10NAPROXEN
28ANDA074182_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1996-06-27NAPROXEN
29ANDA074182_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1996-06-27NAPROXEN
30ANDA074182_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1996-06-27NAPROXEN
31ANDA074195_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
32ANDA074195_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
33ANDA074198_001RXNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalseAB1993-12-21NAPROXEN SODIUM
34ANDA074198_002RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalseAB1993-12-21NAPROXEN SODIUM
35ANDA074201_001RXNAPROXEN (250MG)ORALTABLETFalseAB1993-12-21NAPROXEN
36ANDA074201_002RXNAPROXEN (375MG)ORALTABLETFalseAB1993-12-21NAPROXEN
37ANDA074201_003RXNAPROXEN (500MG)ORALTABLETFalseAB1993-12-21NAPROXEN
38ANDA074207_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1993-12-21NAPROXEN
39ANDA074207_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1993-12-21NAPROXEN
40ANDA074207_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1993-12-21NAPROXEN
41ANDA074211_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1994-02-28NAPROXEN
42ANDA074211_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1994-02-28NAPROXEN
43ANDA074211_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1994-02-28NAPROXEN
44ANDA074216_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1996-04-11NAPROXEN
45ANDA074216_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1996-04-11NAPROXEN
46ANDA074216_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1996-04-11NAPROXEN
47ANDA074230_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1995-03-14NAPROXEN SODIUM
48ANDA074230_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1995-03-14NAPROXEN SODIUM
49ANDA074242_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1996-06-20NAPROXEN SODIUM
50ANDA074242_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1996-06-20NAPROXEN SODIUM
51ANDA074257_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
52ANDA074257_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1993-12-21NAPROXEN SODIUM
53ANDA074263_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1993-12-21NAPROXEN
54ANDA074263_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1993-12-21NAPROXEN
55ANDA074263_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1993-12-21NAPROXEN
56ANDA074289_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1994-01-27NAPROXEN SODIUM
57ANDA074289_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1994-01-27NAPROXEN SODIUM
58ANDA074319_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1995-03-20NAPROXEN SODIUM
59ANDA074319_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1995-03-20NAPROXEN SODIUM
60ANDA074367_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1994-08-31NAPROXEN SODIUM
61ANDA074367_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1994-08-31NAPROXEN SODIUM
62ANDA074410_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1995-04-28NAPROXEN
63ANDA074410_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1995-04-28NAPROXEN
64ANDA074410_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1995-04-28NAPROXEN
65ANDA074455_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1995-05-31NAPROXEN SODIUM
66ANDA074455_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1995-05-31NAPROXEN SODIUM
67ANDA074457_001discontinuedNAPROXEN (250MG)ORALTABLETFalse1995-05-31NAPROXEN
68ANDA074457_002discontinuedNAPROXEN (375MG)ORALTABLETFalse1995-05-31NAPROXEN
69ANDA074457_003discontinuedNAPROXEN (500MG)ORALTABLETFalse1995-05-31NAPROXEN
70ANDA074480_001RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalseAB1996-05-14NAPROXEN SODIUM
71ANDA074480_002RXNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalseAB1998-02-18NAPROXEN SODIUM
72ANDA074495_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse1994-12-05NAPROXEN SODIUM
73ANDA074495_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse1994-12-05NAPROXEN SODIUM
74ANDA074635_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse1997-01-13NAPROXEN SODIUM
75ANDA074646_001discontinuedNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse1997-01-13NAPROXEN SODIUM
76ANDA074661_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse1997-01-13NAPROXEN SODIUM
77ANDA074789_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse1997-02-27NAPROXEN SODIUM
78ANDA074936_001discontinuedNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalse1998-02-24NAPROXEN
79ANDA074936_002discontinuedNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalse1998-02-24NAPROXEN
80ANDA075061_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB1998-02-18NAPROXEN
81ANDA075061_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB1998-02-18NAPROXEN
82ANDA075168_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse1998-07-28NAPROXEN SODIUM
83ANDA075227_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB1998-06-30NAPROXEN
84ANDA075227_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB1998-06-30NAPROXEN
85ANDA075337_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB1999-05-26NAPROXEN
86ANDA075337_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB1999-05-26NAPROXEN
87ANDA075390_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB2001-04-19NAPROXEN
88ANDA075390_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB2001-04-19NAPROXEN
89ANDA075927_001RXNAPROXEN (250MG)ORALTABLETFalseAB2001-12-18NAPROXEN
90ANDA075927_002RXNAPROXEN (375MG)ORALTABLETFalseAB2001-12-18NAPROXEN
91ANDA075927_003RXNAPROXEN (500MG)ORALTABLETFalseAB2001-12-18NAPROXEN
92ANDA076494_001RXNAPROXEN (250MG)ORALTABLETFalseAB2004-01-14NAPROXEN
93ANDA076494_002RXNAPROXEN (375MG)ORALTABLETFalseAB2004-01-14NAPROXEN
94ANDA076494_003RXNAPROXEN (500MG)ORALTABLETFalseAB2004-01-14NAPROXEN
95ANDA076544_001discontinuedNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalse2003-08-22NAPROXEN SODIUM
96ANDA076544_002discontinuedNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalse2003-08-22NAPROXEN SODIUM
97ANDA077339_001RXNAPROXEN (250MG)ORALTABLETFalseAB2005-04-27NAPROXEN
98ANDA077339_002RXNAPROXEN (375MG)ORALTABLETFalseAB2005-04-27NAPROXEN
99ANDA077339_003RXNAPROXEN (500MG)ORALTABLETFalseAB2005-04-27NAPROXEN
100ANDA078250_001RXNAPROXEN (250MG)ORALTABLETFalseAB2007-03-28NAPROXEN
101ANDA078250_002RXNAPROXEN (375MG)ORALTABLETFalseAB2007-03-28NAPROXEN
102ANDA078250_003RXNAPROXEN (500MG)ORALTABLETFalseAB2007-03-28NAPROXEN
103ANDA078314_001RXNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalseAB2007-04-27NAPROXEN SODIUM
104ANDA078314_002RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalseAB2007-04-27NAPROXEN SODIUM
105ANDA078432_001RXNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalseAB2007-04-25NAPROXEN SODIUM
106ANDA078432_002RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalseAB2007-04-25NAPROXEN SODIUM
107ANDA078486_001RXNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalseAB2007-07-26NAPROXEN SODIUM
108ANDA078486_002RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalseAB2007-07-26NAPROXEN SODIUM
109ANDA078620_001RXNAPROXEN (250MG)ORALTABLETFalseAB2007-06-07NAPROXEN
110ANDA078620_002RXNAPROXEN (375MG)ORALTABLETFalseAB2007-06-07NAPROXEN
111ANDA078620_003RXNAPROXEN (500MG)ORALTABLETFalseAB2007-06-07NAPROXEN
112ANDA079096_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse2008-12-16NAPROXEN SODIUM
113ANDA090545_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse2011-03-16NAPROXEN SODIUM
114ANDA091183_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse2011-05-20NAPROXEN SODIUM
115ANDA091305_001RXNAPROXEN (250MG)ORALTABLETFalseAB2011-08-24NAPROXEN
116ANDA091305_002RXNAPROXEN (375MG)ORALTABLETFalseAB2011-08-24NAPROXEN
117ANDA091305_003RXNAPROXEN (500MG)ORALTABLETFalseAB2011-08-24NAPROXEN
118ANDA091353_001OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETFalse2011-09-20NAPROXEN SODIUM
119ANDA091416_001RXNAPROXEN (250MG)ORALTABLETFalseAB2011-02-14NAPROXEN
120ANDA091416_002RXNAPROXEN (375MG)ORALTABLETFalseAB2011-02-14NAPROXEN
121ANDA091416_003RXNAPROXEN (500MG)ORALTABLETFalseAB2011-02-14NAPROXEN
122ANDA091432_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB2011-09-19NAPROXEN
123ANDA091432_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB2011-09-19NAPROXEN
124ANDA200429_001RXNAPROXEN (250MG)ORALTABLETFalseAB2011-11-08NAPROXEN
125ANDA200429_002RXNAPROXEN (375MG)ORALTABLETFalseAB2011-11-08NAPROXEN
126ANDA200429_003RXNAPROXEN (500MG)ORALTABLETFalseAB2011-11-08NAPROXEN
127ANDA200629_001RXNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalseAB2011-10-31NAPROXEN SODIUM
128ANDA200629_002RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETFalseAB2011-10-31NAPROXEN SODIUM
129NDA017581_002RXNAPROXEN (250MG)ORALTABLETFalseABNAPROSYN
130NDA017581_003RXNAPROXEN (375MG)ORALTABLETFalseABNAPROSYN
131NDA017581_004RXNAPROXEN (500MG)ORALTABLETTrueAB1982-04-15NAPROSYN
132NDA018164_001RXNAPROXEN SODIUM (EQ 250MG BASE)ORALTABLETFalseABANAPROX
133NDA018164_003RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLETTrueAB1987-09-30ANAPROX
134NDA020067_002RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASETrueAB1994-10-14EC-NAPROSYN
135NDA020067_003RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASETrueAB1994-10-14EC-NAPROSYN
136NDA020204_002OTCNAPROXEN SODIUM (EQ 200MG BASE)ORALTABLETTrue1994-01-11ALEVE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
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Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII