Naproxen Delayed Release Oral Tablet

Brand(s)
Naprosyn
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genentech, Inc. (2013-04-05)
Oldest Current Product
1994-10-14
License(s)
NDA, ANDA
RxNORM
DELAYED RELEASE ORAL TABLET\NAPROXEN
FDAOB
ORAL\TABLET, DELAYED RELEASE\NAPROXEN
SPL Active
ORAL\TABLET, DELAYED RELEASE\NAPROXEN
ORAL\TABLET\NAPROXEN
SPL Moiety
ORAL\TABLET, DELAYED RELEASE\NAPROXEN
ORAL\TABLET\NAPROXEN

product(s) by strength(s)

naproxen 375 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000046415NaprosynNDAGenentech, Inc.1994-10-14NAPROXENORALTABLET, DELAYED RELEASENDA02006768848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931005ANDATeva Pharmaceuticals Usa Inc1998-07-31NAPROXENORALTABLET, DELAYED RELEASEANDA075227bc6a65ea-9fdf-42a4-972d-5a602d9a0a61
2317220338ANDACamber Pharmaceuticals, Inc.2012-01-23NAPROXENORALTABLETANDA091432cb3897b7-d4f1-4081-bb3c-e5e270a84930

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1332610082ANDAAidarex Pharmaceuticals Llc1998-07-31NAPROXENORALTABLET, DELAYED RELEASE000931005ANDA07522714e4b008-ae31-4b40-a227-1445367e09ed
2422910629ANDAAvkare, Inc.2013-10-24NAPROXENORALTABLET317220338ANDA091432d17048e2-02a9-d33f-f129-154e36213fdd

naproxen 500 mg delayed release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000046416NaprosynNDAGenentech, Inc.1994-10-14NAPROXENORALTABLET, DELAYED RELEASENDA02006768848217-03c9-4377-9be6-6f567e629129

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931006ANDATeva Pharmaceuticals Usa Inc1998-07-29NAPROXENORALTABLET, DELAYED RELEASEANDA075227bc6a65ea-9fdf-42a4-972d-5a602d9a0a61
2317220339ANDACamber Pharmaceuticals, Inc.2012-01-23NAPROXENORALTABLETANDA091432cb3897b7-d4f1-4081-bb3c-e5e270a84930

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440920ANDABlenheim Pharmacal, Inc.2015-06-04NAPROXENORALTABLET317220339ANDA09143217c8f200-7f6e-6e6b-e054-00144ff88e88
2165900164ANDAStat Rx Usa Llc2010-09-23NAPROXENORALTABLET, DELAYED RELEASE000931006ANDA075227d2cf1ee5-df93-4d3f-a79d-d04b0426e3f2
3216950343ANDARebel Distributors Corp2010-06-02NAPROXENORALTABLET, DELAYED RELEASE000931005ANDA075227afebcc90-e2b5-416d-a041-db2dd593a648
4332610083ANDAAidarex Pharmaceuticals Llc1998-07-29NAPROXENORALTABLET, DELAYED RELEASE000931006ANDA07522714e4b008-ae31-4b40-a227-1445367e09ed
5422910630ANDAAvkare, Inc.2013-10-24NAPROXENORALTABLET317220339ANDA091432d17048e2-02a9-d33f-f129-154e36213fdd
6499990897ANDALake Erie Medical Dba Quality Care Products Llc2011-02-03NAPROXENORALTABLET, DELAYED RELEASE000931006ANDA07522716a1566c-b4d9-46a7-9dce-050b1d1cd5d2
7516550628ANDANorthwind Pharmaceuticals, Llc2014-05-16NAPROXENORALTABLET, DELAYED RELEASE317220339ANDA091432c66b0b05-84b4-4f0c-82b2-f0c386f6f64f
8529590516ANDAH.J. Harkins Company, Inc.2010-09-23NAPROXENORALTABLET, DELAYED RELEASE000931006ANDA075227cce0199c-40e9-4c8c-b04c-c2b969e9a5ba
9548684051ANDAPhysicians Total Care, Inc.2002-01-11NAPROXENORALTABLET, DELAYED RELEASE573150030ANDA075390635f8a00-0048-4421-9f5f-f8e38034f230
10552890307ANDAPd-Rx Pharmaceuticals, Inc.2010-09-23NAPROXENORALTABLET, DELAYED RELEASE000931006ANDA075227779277af-dcd9-45b5-adeb-2cfdf3c001de
11636293795ANDABryant Ranch Prepack2010-06-02NAPROXENORALTABLET, DELAYED RELEASE000931006ANDA075227669e5dc4-21ef-7a2d-d232-edc47c5716c5
12681512609ANDACarilion Materials Management1998-07-29NAPROXENORALTABLET, DELAYED RELEASE000931006ANDA075227d22cabc5-c4c6-4063-877b-251a99b0560a

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA074936NAPROXENTrueACTAVIS ELIZABETH LLC1998-02-24ANDA074936_001, ANDA074936_002Naproxen Oral Tablet
2ANDA075061NAPROXENSANDOZ INC1998-02-18ANDA075061_001, ANDA075061_002Naproxen Oral Tablet
3ANDA075227NAPROXENTEVA PHARMACEUTICALS USA INC1998-06-30ANDA075227_001, ANDA075227_002Naproxen Oral Tablet
4ANDA075337NAPROXENPLIVA INC1999-05-26ANDA075337_001, ANDA075337_002Naproxen Oral Tablet
5ANDA075390NAPROXENMYLAN PHARMACEUTICALS INC2001-04-19ANDA075390_001, ANDA075390_002Naproxen Oral Tablet
6ANDA091432NAPROXENINVAGEN PHARMACEUTICALS INC2011-09-19ANDA091432_001, ANDA091432_002Naproxen Oral Tablet
7NDA020067EC-NAPROSYNROCHE PALO ALTO LLC1994-10-14NDA020067_002, NDA020067_003Naproxen Oral Tablet

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA074936_001discontinuedNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalse1998-02-24NAPROXEN
2ANDA074936_002discontinuedNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalse1998-02-24NAPROXEN
3ANDA075061_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB1998-02-18NAPROXEN
4ANDA075061_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB1998-02-18NAPROXEN
5ANDA075227_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB1998-06-30NAPROXEN
6ANDA075227_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB1998-06-30NAPROXEN
7ANDA075337_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB1999-05-26NAPROXEN
8ANDA075337_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB1999-05-26NAPROXEN
9ANDA075390_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB2001-04-19NAPROXEN
10ANDA075390_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB2001-04-19NAPROXEN
11ANDA091432_001RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASEFalseAB2011-09-19NAPROXEN
12ANDA091432_002RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASEFalseAB2011-09-19NAPROXEN
13NDA020067_002RXNAPROXEN (375MG)ORALTABLET, DELAYED RELEASETrueAB1994-10-14EC-NAPROSYN
14NDA020067_003RXNAPROXEN (500MG)ORALTABLET, DELAYED RELEASETrueAB1994-10-14EC-NAPROSYN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
114e4b008-ae31-4b40-a227-1445367e09ed (view SPL)NAPROXEN DELAYED-RELEASE TABLETS USP10051006Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-161332610082, 332610083
216a1566c-b4d9-46a7-9dce-050b1d1cd5d2 (view SPL)NAPROXEN DELAYED-RELEASE TABLETS10051006Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, repack2011-01-172091499990897
317c8f200-7f6e-6e6b-e054-00144ff88e88 (view SPL)Naproxen Delayed-release Tablets USP, 375 mg and 500 mgprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-06-052105440920
4635f8a00-0048-4421-9f5f-f8e38034f230 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-08-171548684051
5669e5dc4-21ef-7a2d-d232-edc47c5716c5 (view SPL)NAPROXEN DELAYED-RELEASE TABLETSprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636293795
668848217-03c9-4377-9be6-6f567e629129 (view SPL)EC-NAPROSYN (naproxen delayed-release tablets) NAPROSYN (naproxen tablets) ANAPROX/ANAPROX DS (naproxen sodium tablets) NAPROSYN (naproxen suspension)prescriptionHuman PrescriptionGenentech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2013-04-0518000046415, 000046416, 000040028, 000046202, 000046203, 000046313, 000046314, 000046316Naproxen Oral Suspension
Naproxen Oral Tablet
7779277af-dcd9-45b5-adeb-2cfdf3c001de (view SPL)NAPROXEN DELAYED-RELEASE TABLETS USP10051006Rx onlyprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2010-09-236552890307
8afebcc90-e2b5-416d-a041-db2dd593a648 (view SPL)NAPROXEN DELAYED-RELEASE TABLETS Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950343
9bc6a65ea-9fdf-42a4-972d-5a602d9a0a61 (view SPL)NAPROXEN DELAYED-RELEASE TABLETS USP10051006Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2013-05-106000931005, 000931006
10c66b0b05-84b4-4f0c-82b2-f0c386f6f64f (view SPL)prescriptionHuman PrescriptionNorthwind Pharmaceuticals, Llcrepack2014-06-031516550628
11cb3897b7-d4f1-4081-bb3c-e5e270a84930 (view SPL)Naproxen Delayed-release Tablets USP, 375 mg and 500 mgprescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.ANALYSIS, MANUFACTURE2012-02-011317220338, 317220339
12cce0199c-40e9-4c8c-b04c-c2b969e9a5ba (view SPL)NAPROXEN DELAYED-RELEASE TABLETS USP10051006Rx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-10-121529590516
13d17048e2-02a9-d33f-f129-154e36213fdd (view SPL)Naproxen Delayed-release Tablets USP, 375 mg and 500 mgprescriptionHuman PrescriptionAvkare, Inc.2013-11-052422910629, 422910630
14d22cabc5-c4c6-4063-877b-251a99b0560a (view SPL)NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2013-05-102681512609
15d2cf1ee5-df93-4d3f-a79d-d04b0426e3f2 (view SPL)NAPROXEN DELAYED-RELEASE TABLETS USP1006Rx onlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-08-021165900164

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