Naproxen Extended Release Oral Tablet

Brand(s)
Naprelan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alvogen, Inc. (2014-01-17)
Oldest Current Product
1996-01-05
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\NAPROXEN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\NAPROXEN SODIUM
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NAPROXEN SODIUM
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\NAPROXEN

product(s) by strength(s)

24 hr naproxen 375 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300375NaprelanNDAShionogi Inc.1996-04-01NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA02035315ab6690-53bf-4669-950f-35db4dba8fac
2684530375NaprelanNDAVictory Pharmaceutical1996-01-05NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA02035309c49d97-1423-4527-aaf0-fc2eb6688487

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810153NDA AUTHORIZED GENERICAlvogen, Inc.2015-03-11NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA0203539225acaa-209f-958b-2c51-9a46995dec33
2620370825ANDAActavis Pharma, Inc.2014-09-30NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASEANDA07541614496afb-a541-4b01-a672-fcd411292b8d

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950905NaprelanNDARebel Distributors Corp1996-01-05NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE684530375NDA0203531f949140-68b5-4602-936f-1936e436d553
2548683974NaprelanNDAPhysicians Total Care, Inc.2005-08-19NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE684530375NDA020353a95509ce-49a8-4b2c-a533-27c322949bca
3636294146NaprelanNDABryant Ranch Prepack1996-01-05NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE684530375NDA0203535ce2bc19-008b-8cf7-9d4e-ddad656b4f03

24 hr naproxen 500 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1524270273NaprelanNDAAlmatica Pharma Inc.2014-01-17NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA020353e633ff0b-eab7-f167-8d08-e9236e54042b
2684530850NaprelanNDAVictory Pharmaceutical1996-01-05NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA02035309c49d97-1423-4527-aaf0-fc2eb6688487

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810154NDA AUTHORIZED GENERICAlvogen, Inc.2015-03-11NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA0203539225acaa-209f-958b-2c51-9a46995dec33
2620370826ANDAActavis Pharma, Inc.2014-09-30NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASEANDA07541614496afb-a541-4b01-a672-fcd411292b8d

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950906NaprelanNDARebel Distributors Corp1996-01-05NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE684530850NDA0203531f949140-68b5-4602-936f-1936e436d553
2353560530NaprelanNDALake Erie Medical Dba Quality Care Products Llc2011-11-29NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE684530850NDA020353ffed73dc-02af-4adf-82d1-2817efbe4267

24 hr naproxen 750 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1524270274NaprelanNDAAlmatica Pharma Inc.2014-01-17NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA020353e633ff0b-eab7-f167-8d08-e9236e54042b
2684530777NaprelanNDAVictory Pharmaceutical2008-12-19NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA02035309c49d97-1423-4527-aaf0-fc2eb6688487

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1477810155NDA AUTHORIZED GENERICAlvogen, Inc.2015-03-11NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA0203539225acaa-209f-958b-2c51-9a46995dec33

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900242NaprelanNDAStat Rx Usa Llc2008-12-19NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE684530777NDA020353e84a9de5-a027-4c2e-99f9-a270f8f7783e
2430630242NaprelanNDAPd-Rx Pharmaceuticals, Inc.2008-12-19NAPROXEN SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE684530777NDA020353d67a14a5-6bdb-4e09-8056-c7186a95f3bd

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075416NAPROXEN SODIUMACTAVIS LABORATORIES FL INC2002-08-27ANDA075416_001, ANDA075416_002
2NDA020353NAPRELANALVOGEN MALTA OPERATIONS LTD1996-01-05NDA020353_001, NDA020353_002, NDA020353_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075416_001RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2002-08-27NAPROXEN SODIUM
2ANDA075416_002RXNAPROXEN SODIUM (EQ 375MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB2003-04-23NAPROXEN SODIUM
3NDA020353_001RXNAPROXEN SODIUM (EQ 375MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB1996-01-05NAPRELAN
4NDA020353_002RXNAPROXEN SODIUM (EQ 500MG BASE)ORALTABLET, EXTENDED RELEASEFalseAB1996-01-05NAPRELAN
5NDA020353_003RXNAPROXEN SODIUM (EQ 750MG BASE)ORALTABLET, EXTENDED RELEASETrue1996-01-05NAPRELAN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
109c49d97-1423-4527-aaf0-fc2eb6688487 (view SPL)NAPRELAN (naproxen sodium) CONTROLLED-RELEASE TABLETSprescriptionHuman PrescriptionVictory Pharmaceutical2009-08-012684530375, 684530777, 684530850, 684530900
214496afb-a541-4b01-a672-fcd411292b8d (view SPL)NAPROXEN SODIUM EXTENDED-RELEASETABLETS Revised: July 2014 Rx Only 224036-1prescriptionHuman PrescriptionActavis Pharma, Inc.2014-07-017620370825, 620370826
315ab6690-53bf-4669-950f-35db4dba8fac (view SPL)NaprelanprescriptionHuman PrescriptionShionogi Inc.MANUFACTURE2013-08-225596300375, 596300777, 596300850
41f949140-68b5-4602-936f-1936e436d553 (view SPL)NAPRELAN (naproxen sodium) CONTROLLED-RELEASE TABLETSprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-12-291216950905, 216950906
55ce2bc19-008b-8cf7-9d4e-ddad656b4f03 (view SPL)NAPRELAN (naproxen sodium) CONTROLLED-RELEASE TABLETSprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-184636294146
69225acaa-209f-958b-2c51-9a46995dec33 (view SPL)Naproxen Sodium Controlled Release TabletsprescriptionHuman PrescriptionAlvogen, Inc.manufacture, pack2014-01-171477810153, 477810154, 477810155
7a95509ce-49a8-4b2c-a533-27c322949bca (view SPL)NAPRELAN (naproxen sodium) CONTROLLED-RELEASE TABLETSprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-08-011548683974
8d67a14a5-6bdb-4e09-8056-c7186a95f3bd (view SPL)NAPRELAN (naproxen sodium) CONTROLLED-RELEASE TABLETSprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-08-012430630242
9e633ff0b-eab7-f167-8d08-e9236e54042b (view SPL)NaprelanprescriptionHuman PrescriptionAlmatica Pharma Inc.manufacture, pack2014-01-172524270273, 524270274, 524270272
10e84a9de5-a027-4c2e-99f9-a270f8f7783e (view SPL)NAPRELAN (naproxen sodium) CONTROLLED-RELEASE TABLETSprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2010-03-151165900242
11ffed73dc-02af-4adf-82d1-2817efbe4267 (view SPL)NAPRELAN (naproxen sodium) CONTROLLED-RELEASE TABLETSprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-11-293264353560530

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII