Diclofenac Extended Release Oral Tablet

Brand(s)
Voltaren
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2011-02-23)
Oldest Current Product
1996-03-08
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL TABLET\DICLOFENAC
FDAOB
ORAL\TABLET, EXTENDED RELEASE\DICLOFENAC SODIUM
SPL Active
ORAL\TABLET, EXTENDED RELEASE\DICLOFENAC SODIUM
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\DICLOFENAC SODIUM
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\DICLOFENAC
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\DICLOFENAC

product(s) by strength(s)

24 hr diclofenac sodium 100 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780446VoltarenNDANovartis Pharmaceuticals Corporation1996-03-08DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA0202549e2244cb-f50f-4fbb-b6b8-acbba8459081

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000931041ANDATeva Pharmaceuticals Usa Inc2000-02-28DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASEANDA0754921d1d442c-b423-4843-a15b-197dbfeb5df1
2002282717ANDAActavis Elizabeth Llc2002-01-09DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASEANDA075910a8c96721-fc32-41a1-ac15-05c984210784
3003780355ANDAMylan Pharmaceuticals Inc.2002-02-15DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASEANDA076152ffbf7573-c726-42f6-bbd5-5d2533d8288f
4005910676ANDAWatson Laboratories, Inc.2002-11-06DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASEANDA0762014c1e3237-288d-4d30-b8e9-8a935602ee17
5007811381NDA AUTHORIZED GENERICSandoz Inc1996-03-08DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASENDA02025493879f33-d484-471d-94e2-a5ba37eb44d5

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440928ANDABlenheim Pharmacal, Inc.2015-06-02DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE005910676ANDA076201753dd45e-7135-438a-9aa7-990cf5f97c6d
2216950040ANDARebel Distributors Corp2002-01-07DICLOFENAC SODIUMORALTABLET, EXTENDED RELEASE002282717ANDA075910688fa1d0-6e17-4191-8618-8f62bc7765d3
3333580451NDA AUTHORIZED GENERICRxchange Co.2014-11-26DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE007811381NDA02025401e92b73-8271-4028-8a74-c236e3b55db8
4353560776ANDALake Erie Medical Dba Quality Care Products Llc2002-01-09DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE002282717ANDA0759109d522742-7f29-47eb-9e96-c08482975bee
5353560867NDALake Erie Medical Dba Quality Care Products Llc1996-03-08DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE007811381NDA0202542b0c2fc7-800c-4d5e-914c-9e67a54b1e2a
6430630270ANDAPd-Rx Pharmaceuticals, Inc.2010-01-27DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE003780355ANDA076152a1339d2d-066e-459c-93b7-1ba839b15e2e
7430630543NDA AUTHORIZED GENERICPd-Rx Pharmaceuticals, Inc.1996-03-08DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE007811381NDA020254afff07ab-9440-4448-8768-359a5dda202e
8458650364ANDAMedsource Pharmaceuticals2009-01-05DICLOFENAC SODIUMORALTABLET, EXTENDED RELEASE002282717ANDA075910d349b4ca-3aec-44a8-a4d5-87be4c822190
9493490939ANDARemedyrepack Inc.2012-03-28DICLOFENAC SODIUMORALTABLET, EXTENDED RELEASE002282717ANDA075910d7a65845-41d3-4859-b29d-513cffc6d0be
10548685011ANDAPhysicians Total Care, Inc.2004-03-02DICLOFENAC SODIUMORALTABLET, EXTENDED RELEASE002282717ANDA07591042fcf2b5-3466-4493-8a47-c4675538ece3
11607600271ANDASt Marys Medical Park Pharmacy2002-01-07DICLOFENAC SODIUMORALTABLET, EXTENDED RELEASE002282717ANDA07591097532b47-41c4-41e5-a89b-fc788528204b
12619190468ANDADirect Rx2015-01-01DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE005910676ANDA0762017cf9cdc3-6837-4b64-b967-9d15f3b0bdc4
13619190838ANDADirect Rx2014-01-01DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE002282717ANDA07591074bb5cb3-03e0-4dbf-9b8a-f67417538e4f
14631870041NDAProficient Rx Lp1996-03-08DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE007811381NDA020254d512ea2e-a4b5-4ff9-b972-a9bf86ea9937
15631870475ANDAProficient Rx Lp2002-11-06DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE005910676ANDA0762018e0913b3-2b0c-41b6-bbfe-10aa3262e1dc
16636293941ANDABryant Ranch Prepack2004-03-02DICLOFENAC SODIUMORALTABLET, EXTENDED RELEASE002282717ANDA075910d77f1654-4423-464f-a846-6767a2377ce1
17636295096NDA AUTHORIZED GENERICBryant Ranch Prepack1996-03-08DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE007811381NDA020254b3d2ceba-34b3-419f-808b-e10cf0c15a3a
18687889389NDA AUTHORIZED GENERICPreferred Pharmaceuticals, Inc.2014-07-17DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE007811381NDA0202541f5a4b8e-458d-43f1-a1e9-fac0df45954e
19687889412ANDAPreferred Pharmaceuticals, Inc.2014-06-02DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE000931041ANDA07549269d6802e-86b1-43f7-86ef-982ffd24511d
20687889523ANDAPreferred Pharmaceuticals, Inc.2014-02-03DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE005910676ANDA076201d81dc6f5-7e4e-4fff-81e7-ee83c850c5f7
21687889787ANDAPreferred Pharmaceuticals, Inc.2012-06-04DICLOFENAC SODIUMORALTABLET, FILM COATED, EXTENDED RELEASE002282717ANDA075910c1888b7a-0a14-4e24-9ba7-1458154d07d9

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA075492DICLOFENAC SODIUMVALEANT PHARMACEUTICALS NORTH AMERICA2000-02-11ANDA075492_001
2ANDA075910DICLOFENAC SODIUMACTAVIS ELIZABETH LLC2002-01-07ANDA075910_001
3ANDA076152DICLOFENAC SODIUMMYLAN PHARMACEUTICALS INC2001-12-13ANDA076152_001
4ANDA076201DICLOFENAC SODIUMDEXCEL LTD2002-11-06ANDA076201_001
5NDA020254VOLTAREN-XRNOVARTIS PHARMACEUTICALS CORP1996-03-08NDA020254_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075492_001RXDICLOFENAC SODIUM (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2000-02-11DICLOFENAC SODIUM
2ANDA075910_001RXDICLOFENAC SODIUM (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2002-01-07DICLOFENAC SODIUM
3ANDA076152_001RXDICLOFENAC SODIUM (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2001-12-13DICLOFENAC SODIUM
4ANDA076201_001RXDICLOFENAC SODIUM (100MG)ORALTABLET, EXTENDED RELEASEFalseAB2002-11-06DICLOFENAC SODIUM
5NDA020254_001RXDICLOFENAC SODIUM (100MG)ORALTABLET, EXTENDED RELEASETrueAB1996-03-08VOLTAREN-XR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101e92b73-8271-4028-8a74-c236e3b55db8 (view SPL)Diclofenac SodiumExtended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionRxchange Co.repack2014-12-022333580451
21d1d442c-b423-4843-a15b-197dbfeb5df1 (view SPL)Diclofenac Sodium Extended-release TabletprescriptionHuman PrescriptionTeva Pharmaceuticals Usa IncMANUFACTURE2012-08-078000931041
31f5a4b8e-458d-43f1-a1e9-fac0df45954e (view SPL)Diclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-07-222687889389
42b0c2fc7-800c-4d5e-914c-9e67a54b1e2a (view SPL)DiclofenacprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-05-231353560867
542fcf2b5-3466-4493-8a47-c4675538ece3 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-01-141548685011
64c1e3237-288d-4d30-b8e9-8a935602ee17 (view SPL)Diclofenac Sodium Extended-release TabletsprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, MANUFACTURE, PACK2015-01-015005910676
7688fa1d0-6e17-4191-8618-8f62bc7765d3 (view SPL)DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors Corprelabel, repack2009-06-011216950040
869d6802e-86b1-43f7-86ef-982ffd24511d (view SPL)Diclofenac Sodium Extended-release TabletprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-06-021687889412
974bb5cb3-03e0-4dbf-9b8a-f67417538e4f (view SPL)DICLOFENAC SODIUMprescriptionHuman PrescriptionDirect Rxrelabel, repack2014-12-091619190838
10753dd45e-7135-438a-9aa7-990cf5f97c6d (view SPL)Diclofenac Sodium Extended-release TabletsprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-10-088105440928
117cf9cdc3-6837-4b64-b967-9d15f3b0bdc4 (view SPL)DICLOFENAC SODIUMprescriptionHuman PrescriptionDirect Rxrepack2015-06-301619190468
128e0913b3-2b0c-41b6-bbfe-10aa3262e1dc (view SPL)Diclofenac Sodium Extended-release TabletsprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870475
1393879f33-d484-471d-94e2-a5ba37eb44d5 (view SPL)Diclofenac SodiumExtended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionSandoz Inc2013-06-012007811381
1497532b47-41c4-41e5-a89b-fc788528204b (view SPL)DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2011-09-085607600271
159d522742-7f29-47eb-9e96-c08482975bee (view SPL)Diclofenac Sodium Extended-Release Tablets, USPprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-06-121353560776
169e2244cb-f50f-4fbb-b6b8-acbba8459081 (view SPL)Voltaren -XR (diclofenac sodium extended -release ) tablets , USP Tablets of 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2011-02-232000780446
17a1339d2d-066e-459c-93b7-1ba839b15e2e (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-11-065430630270
18a8c96721-fc32-41a1-ac15-05c984210784 (view SPL)Diclofenac Sodium Extended-Release Tablets, USPprescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, MANUFACTURE, PACK2013-08-225002282717
19afff07ab-9440-4448-8768-359a5dda202e (view SPL)Diclofenac SodiumExtended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2013-06-014430630543
20b3d2ceba-34b3-419f-808b-e10cf0c15a3a (view SPL)Diclofenac SodiumExtended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-101000636295096
21c1888b7a-0a14-4e24-9ba7-1458154d07d9 (view SPL)Diclofenac Sodium Extended-Release Tablets, USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-07-213687889787
22d349b4ca-3aec-44a8-a4d5-87be4c822190 (view SPL)DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS, USPprescriptionHuman PrescriptionMedsource Pharmaceuticals2012-07-242458650364
23d512ea2e-a4b5-4ff9-b972-a9bf86ea9937 (view SPL)Diclofenac Sodium Extended-Release Tablets, USP Tablets of 100 mg Rx only Prescribing InformationprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2014-04-302631870041
24d77f1654-4423-464f-a846-6767a2377ce1 (view SPL)prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2011-01-142636293941
25d7a65845-41d3-4859-b29d-513cffc6d0be (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2012-03-282493490939
26d81dc6f5-7e4e-4fff-81e7-ee83c850c5f7 (view SPL)Diclofenac Sodium Extended-release TabletsprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-11-103687889523
27ffbf7573-c726-42f6-bbd5-5d2533d8288f (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2014-12-296003780355

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