Diclofenac Oral Tablet

Brand(s)
Cataflam
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2011-02-23)
Oldest Current Product
1993-11-24
License(s)
NDA, ANDA
RxNORM
ORAL TABLET\DICLOFENAC
FDAOB
ORAL\TABLET\DICLOFENAC POTASSIUM
SPL Active
ORAL\TABLET, FILM COATED\DICLOFENAC POTASSIUM
ORAL\TABLET, SUGAR COATED\DICLOFENAC POTASSIUM
ORAL\TABLET\DICLOFENAC POTASSIUM
SPL Moiety
ORAL\TABLET, FILM COATED\DICLOFENAC
ORAL\TABLET, SUGAR COATED\DICLOFENAC
ORAL\TABLET\DICLOFENAC

product(s) by strength(s)

diclofenac potassium 50 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780436CataflamNDANovartis Pharmaceuticals Corporation1993-11-24DICLOFENAC POTASSIUMORALTABLET, SUGAR COATEDNDA0201421582c050-925a-4af8-a44f-948017946ae6

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930948ANDATeva Pharmaceuticals Usa Inc1998-08-11DICLOFENAC POTASSIUMORALTABLET, FILM COATEDANDA07521977b60a0c-e49a-4ad4-abb1-b662c24ab782
2003782474ANDAMylan Pharmaceuticals Inc.2012-08-13DICLOFENAC POTASSIUMORALTABLET, FILM COATEDANDA075463fac1f8e7-f2b4-4de3-bd5c-d798d12273c1
3007815017ANDASandoz Inc1998-11-20DICLOFENAC POTASSIUMORALTABLET, FILM COATEDANDA075229a0a86ecf-e6fe-4c85-ac60-f62fd63e2590

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340827ANDAApotheca, Inc2007-08-20DICLOFENAC POTASSIUMORALTABLET605050135ANDA075229645c97bc-5197-45a1-9802-2b4d43bd7496
2165900072ANDAStat Rx Usa Llc2004-03-18DICLOFENAC POTASSIUMORALTABLET, FILM COATED605050135ANDA076561a697e731-8d19-4845-8f31-16c4b19bb338
3216950838ANDARebel Distributors Corp2010-01-21DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA075219d751e65a-5086-4303-864b-bd9ed895a239
4332610038ANDAAidarex Pharmaceuticals Llc1998-08-11DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA07521961c5becd-0295-4e86-9b5b-f8388207da49
5353560713ANDALake Erie Medical Dba Quality Care Products Llc1998-08-11DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA075219236678af-b766-41e7-98f4-bf13c0f39a28
6493490955ANDARemedyrepack Inc.2012-03-30DICLOFENAC POTASSIUMORALTABLET000930948ANDA07521931eaf8b6-5e2a-424c-8830-2c561044cdf8
7499990593ANDALake Erie Medical Dba Quality Care Products Llc2011-12-05DICLOFENAC POTASSIUMORALTABLET, FILM COATED003782474ANDA0754632cc4fc25-1948-445d-aa50-81fc7a5222a5
8529590659ANDAH.J. Harkins Company, Inc.2010-01-21DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA0752190c3ac260-586d-4203-855b-f7518e89484e
9548685437ANDAPhysicians Total Care, Inc.2008-10-15DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA075219ae0257c5-c16e-4c95-83b6-f9ae02792884
10552890781ANDAPd-Rx Pharmaceuticals, Inc.1998-11-20DICLOFENAC POTASSIUMORALTABLET, FILM COATED007815017ANDA0752291728cd89-1bb4-4b55-8e1c-9181702e4c51
11581185017ANDAClinical Solutions Wholesale1998-11-20DICLOFENAC POTASSIUMORALTABLET, FILM COATED007815017ANDA075229ac52a142-bf15-4c1c-b6a6-ab2c1b65726b
12617860404ANDARemedyrepack Inc.2015-09-04DICLOFENAC POTASSIUMORALTABLET, FILM COATED003782474ANDA075463f56d6ee5-e33a-4055-bb86-2b5324e22555
13619190072ANDADirect Rx2014-01-01DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA07521985da6c5c-a1ec-4ea0-9fbb-2012f63931be
14636294108ANDABryant Ranch Prepack2010-01-21DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA075219717341fc-e067-0005-215c-053f6d12e0d1
15681510561ANDACarilion Materials Management1998-08-11DICLOFENAC POTASSIUMORALTABLET, FILM COATED000930948ANDA0752197dfb36a4-3064-4639-9167-23d1c7d1bee9

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA075152DICLOFENAC POTASSIUMTrueWATSON LABORATORIES INC1998-11-27ANDA075152_001
2ANDA075219DICLOFENAC POTASSIUMTEVA PHARMACEUTICALS USA INC1998-08-06ANDA075219_001
3ANDA075229DICLOFENAC POTASSIUMSANDOZ INC1998-11-20ANDA075229_001
4ANDA075463DICLOFENAC POTASSIUMMYLAN PHARMACEUTICALS INC1999-07-26ANDA075463_001
5ANDA075470DICLOFENAC POTASSIUMTrueMUTUAL PHARMACEUTICAL CO INC2002-02-21ANDA075470_001
6ANDA075582DICLOFENAC POTASSIUMTrueSANDOZ INC2001-02-23ANDA075582_001
7ANDA076561DICLOFENAC POTASSIUMAPOTEX INC2004-03-18ANDA076561_001
8NDA020142CATAFLAMNOVARTIS PHARMACEUTICALS CORP1993-11-24NDA020142_001, NDA020142_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075152_001discontinuedDICLOFENAC POTASSIUM (50MG)ORALTABLETFalse1998-11-27DICLOFENAC POTASSIUM
2ANDA075219_001RXDICLOFENAC POTASSIUM (50MG)ORALTABLETFalseAB1998-08-06DICLOFENAC POTASSIUM
3ANDA075229_001RXDICLOFENAC POTASSIUM (50MG)ORALTABLETFalseAB1998-11-20DICLOFENAC POTASSIUM
4ANDA075463_001RXDICLOFENAC POTASSIUM (50MG)ORALTABLETFalseAB1999-07-26DICLOFENAC POTASSIUM
5ANDA075470_001discontinuedDICLOFENAC POTASSIUM (50MG)ORALTABLETFalse2002-02-21DICLOFENAC POTASSIUM
6ANDA075582_001discontinuedDICLOFENAC POTASSIUM (50MG)ORALTABLETFalse2001-02-23DICLOFENAC POTASSIUM
7ANDA076561_001RXDICLOFENAC POTASSIUM (50MG)ORALTABLETFalseAB2004-03-18DICLOFENAC POTASSIUM
8NDA020142_001discontinuedDICLOFENAC POTASSIUM (25MG)ORALTABLETFalse1993-11-24CATAFLAM
9NDA020142_002RXDICLOFENAC POTASSIUM (50MG)ORALTABLETTrueAB1993-11-24CATAFLAM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10c3ac260-586d-4203-855b-f7518e89484e (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mg0948Rx onlyprescriptionHuman PrescriptionH.J. Harkins Company, Inc.manufacture2011-10-171529590659
21582c050-925a-4af8-a44f-948017946ae6 (view SPL)Cataflam ( diclofenac potassium immediate -release tablets ) Tablets of 50 mg Rx only Prescribing InformationprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2011-02-236000780436
31728cd89-1bb4-4b55-8e1c-9181702e4c51 (view SPL)Diclofenac Potassium Tablets, USP 50 mgprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-11-0213552890781
4236678af-b766-41e7-98f4-bf13c0f39a28 (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mg0948Rx onlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-02-071353560713
52cc4fc25-1948-445d-aa50-81fc7a5222a5 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-12-053318499990593
631eaf8b6-5e2a-424c-8830-2c561044cdf8 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-301493490955
761c5becd-0295-4e86-9b5b-f8388207da49 (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mg0948Rx onlyprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2013-12-271332610038
8645c97bc-5197-45a1-9802-2b4d43bd7496 (view SPL)DICLOFENAC POTASSIUM, TABLET USPprescriptionHuman PrescriptionApotheca, Increlabel2013-09-031126340827
9717341fc-e067-0005-215c-053f6d12e0d1 (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2010-01-212636294108
1077b60a0c-e49a-4ad4-abb1-b662c24ab782 (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mg0948Rx onlyprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-05-296000930948
117dfb36a4-3064-4639-9167-23d1c7d1bee9 (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mg 0948 Rx onlyprescriptionHuman PrescriptionCarilion Materials ManagementREPACK2012-08-102681510561
1285da6c5c-a1ec-4ea0-9fbb-2012f63931be (view SPL)DICLOFENAC POTASSIUMprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-04-021619190072
13a0a86ecf-e6fe-4c85-ac60-f62fd63e2590 (view SPL)Diclofenac Potassium Tablets, USP 50 mgprescriptionHuman PrescriptionSandoz Inc2015-03-2414007815017
14a697e731-8d19-4845-8f31-16c4b19bb338 (view SPL)DICLOFENAC POTASSIUM tablet, film coatedprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-272165900072
15ac52a142-bf15-4c1c-b6a6-ab2c1b65726b (view SPL)Diclofenac Potassium Tablets, USP 50 mgprescriptionHuman PrescriptionClinical Solutions Wholesalerelabel, repack2013-06-211581185017
16ae0257c5-c16e-4c95-83b6-f9ae02792884 (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mg0948Rx onlyprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-01-211548685437
17d751e65a-5086-4303-864b-bd9ed895a239 (view SPL)DICLOFENAC POTASSIUM TABLETS USP, 50 mg0948Rx onlyprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-241216950838
18f56d6ee5-e33a-4055-bb86-2b5324e22555 (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2015-09-041617860404
19fac1f8e7-f2b4-4de3-bd5c-d798d12273c1 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2012-07-255003782474

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