Diclofenac Transdermal Patch

Brand(s)
Flector
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pfizer Laboratories Div Pfizer Inc (2012-12-20)
Oldest Current Product
2008-01-14
License(s)
NDA
RxNORM
TRANSDERMAL PATCH\DICLOFENAC
FDAOB
TOPICAL\PATCH\DICLOFENAC EPOLAMINE
SPL Active
TOPICAL\PATCH\DICLOFENAC EPOLAMINE
SPL Moiety
TOPICAL\PATCH\DICLOFENAC

product(s) by strength(s)

12 hr diclofenac epolamine 15 mg/hr transdermal patch

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1607930411FlectorNDAPfizer Laboratories Div Pfizer Inc2008-01-14DICLOFENAC EPOLAMINETOPICALPATCHNDA021234f103f7e8-1253-43cb-9667-cd0d8f4d5500

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950707FlectorNDARebel Distributors Corp2008-11-17DICLOFENAC EPOLAMINETOPICALPATCH638570111NDA021234e58641de-b6fd-484c-8902-b9262d7ce251
2353560077FlectorNDALake Erie Medical Dba Quality Care Products Llc2011-11-11DICLOFENAC EPOLAMINETOPICALPATCH640320005NDA02123459e94a55-08b6-4d04-bc10-9911e5a585e0
3422540248FlectorNDARebel Distributors Corp2008-01-14DICLOFENAC EPOLAMINETOPICALPATCH607930411NDA0212342b810942-e143-4e4f-8820-00af4f2e0c1e
4425490606FlectorNDAStat Rx Usa Llc2008-06-08DICLOFENAC EPOLAMINETOPICALPATCH638570111NDA0212342cc5e92b-044b-46a4-85eb-bcfe04c9d4be
5504361332FlectorNDAUnit Dose Services2008-01-14DICLOFENAC EPOLAMINETOPICALPATCH607930411NDA021234f8b489ee-b48f-41b6-a759-c910e531576f
6529590518FlectorNDAH.J. Harkins Company, Inc.2008-01-14DICLOFENAC EPOLAMINETOPICALPATCH607930411NDA0212344bca1472-9a43-4510-a2de-5a2d80edbfbc
7548685962FlectorNDAPhysicians Total Care, Inc.2008-11-17DICLOFENAC EPOLAMINETOPICALPATCH638570111NDA0212345e46b7e9-e640-4db5-882f-73a5dd2482d2
8617860026FlectorNDARemedyrepack Inc.2014-09-11DICLOFENAC EPOLAMINETOPICALPATCH607930411NDA021234747027fa-d638-4fc6-9cd5-d3680fc3f809
9619190566NDADirect Rx2014-01-01DICLOFENAC EPOLAMINETOPICALPATCH607930411NDA0212340f11e37c-1aa4-455a-98b8-6aae72294a25
10636294762FlectorNDABryant Ranch Prepack2008-01-14DICLOFENAC EPOLAMINETOPICALPATCH607930411NDA02123456caa44c-cc65-4500-ae05-ed508e52075d

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021234FLECTORINSTITUT BIOCHEMIQUE SA2007-01-31p5607690, SUBSTANCENDA021234_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021234_001RXDICLOFENAC EPOLAMINE (1.3%)TOPICALPATCHTrue2007-01-31FLECTOR

patent(s)

#idexpiration dateapplication(s)
1p5607690 (view patent)2019-04-13NDA021234

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10f11e37c-1aa4-455a-98b8-6aae72294a25 (view SPL)FLECTORprescriptionHuman PrescriptionDirect Rxrelabel2014-12-111619190566
22b810942-e143-4e4f-8820-00af4f2e0c1e (view SPL)These highlights do not include all the information needed to use FLECTOR PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 1988prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2012-07-171422540248
32cc5e92b-044b-46a4-85eb-bcfe04c9d4be (view SPL)Flector Patch (diclofenac epolamine topical patch) 1.3%prescriptionHuman PrescriptionStat Rx Usa LlcRELABEL, REPACK2012-02-216425490606
44bca1472-9a43-4510-a2de-5a2d80edbfbc (view SPL)These highlights do not include all the information needed to use FLECTOR PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 1988prescriptionHuman PrescriptionH.J. Harkins Company, Inc.relabel, repack2012-01-193529590518
556caa44c-cc65-4500-ae05-ed508e52075d (view SPL)These highlights do not include all the information needed to use FLECTOR PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 1988prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636294762
659e94a55-08b6-4d04-bc10-9911e5a585e0 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcmanufacture, relabel2011-11-113142353560077
75e46b7e9-e640-4db5-882f-73a5dd2482d2 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-06-021548685962
8747027fa-d638-4fc6-9cd5-d3680fc3f809 (view SPL)These highlights do not include all the information needed to use FLECTOR PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 1988prescriptionHuman PrescriptionRemedyrepack Inc.2014-09-111617860026
9e58641de-b6fd-484c-8902-b9262d7ce251 (view SPL)Flector Patch (diclofenac epolamine topical patch) 1.3%prescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-09-272216950707
10f103f7e8-1253-43cb-9667-cd0d8f4d5500 (view SPL)These highlights do not include all the information needed to use FLECTOR PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 1988prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer Inc2012-12-206607930411
11f8b489ee-b48f-41b6-a759-c910e531576f (view SPL)These highlights do not include all the information needed to use FLECTOR PATCH 1.3% safely and effectively. See full prescribing information for FLECTOR PATCH. FLECTOR PATCH (diclofenac epolamine patch) 1.3% Initial U.S. Approval: 1988prescriptionHuman PrescriptionUnit Dose ServicesREPACK2011-11-012504361332

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