Raloxifene Oral Tablet

Brand(s)
Evista
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eli Lilly And Company (2015-02-09)
Oldest Current Product
1998-01-06
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\RALOXIFENE
FDAOB
ORAL\TABLET\RALOXIFENE HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED\RALOXIFENE HYDROCHLORIDE
ORAL\TABLET\RALOXIFENE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED\RALOXIFENE
ORAL\TABLET\RALOXIFENE

product(s) by strength(s)

raloxifene hydrochloride 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000024165EvistaNDAEli Lilly And Company1998-01-06RALOXIFENE HYDROCHLORIDEORALTABLETNDA020815fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937290ANDATeva Pharmaceuticals Usa Inc2014-03-28RALOXIFENE HYDROCHLORIDEORALTABLET, FILM COATEDANDA078193e6be5b1d-757d-4bab-ad6a-c421960a104d
2005912367ANDAWatson Laboratories, Inc.2015-06-18RALOXIFENE HYDROCHLORIDEORALTABLET, FILM COATEDANDA200825f9eeef29-f34d-4261-b8c3-499f31365b33
3317220256ANDACamber Pharmaceuticals, Inc.2014-09-24RALOXIFENE HYDROCHLORIDEORALTABLETANDA0908428f4fe353-c5de-44ba-9c68-b75a185f7dc5
4658620709ANDAAurobindo Pharma Limited2015-08-28RALOXIFENE HYDROCHLORIDEORALTABLET, FILM COATEDANDA204310e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5
5669930417NDA AUTHORIZED GENERICPrasco Laboratories2014-03-01RALOXIFENE HYDROCHLORIDEORALTABLETNDA0208153385dd3d-c096-4957-8ba2-d91630f655ea
6669930661ANDAPrasco Laboratories2015-08-28RALOXIFENE HYDROCHLORIDEORALTABLET, FILM COATEDANDA20431044c89f9c-2194-4d33-9bde-f8f309d33ef2
7762820256ANDAExelan Pharmaceuticals Inc.2014-11-12RALOXIFENE HYDROCHLORIDEORALTABLET, FILM COATEDANDA0908422b94ecf5-d870-4132-b455-d5ee5c9dce56

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1001790151NDA AUTHORIZED GENERICKaiser Foundations Hospitals2014-05-29RALOXIFENE HYDROCHLORIDEORALTABLET669930417NDA020815d7282df8-9637-40f7-9004-7198918606a9
2422910726ANDAAvkare, Inc.2014-11-03RALOXIFENE HYDROCHLORIDEORALTABLET, FILM COATED000937290ANDA07819313a872e6-8983-5085-e3d5-8ebcdb6d213e
3499990458EvistaNDALake Erie Medical Dba Quality Care Products Llc2012-03-07RALOXIFENE HYDROCHLORIDEORALTABLET000024165NDA020815cbee500a-34e2-4819-987b-da107eacbb27
4548684170EvistaNDAPhysicians Total Care, Inc.2000-05-11RALOXIFENE HYDROCHLORIDEORALTABLET000024165NDA02081501143c04-f5d7-481d-95bb-d384f2413585
5552890266EvistaNDAPd-Rx Pharmaceuticals, Inc.1998-01-06RALOXIFENE HYDROCHLORIDEORALTABLET000024165NDA020815be68ba7b-19fc-49b0-b9a7-685b11bc0fe0
6680840871ANDAAmerican Health Packaging2014-11-13RALOXIFENE HYDROCHLORIDEORALTABLET317220256ANDA0908427f4bd906-2af7-4f93-af23-6f13b0f5d868
7691890418NDA AUTHORIZED GENERICAvera Mckennan Hospital2015-03-01RALOXIFENE HYDROCHLORIDEORALTABLET669930417NDA0208155982304f-50fa-468b-9982-6e18d356ed01

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1ANDA078193RALOXIFENE HYDROCHLORIDETEVA PHARMACEUTICALS USA2014-03-04PATENT CHALLENGE [2014-09-24]ANDA078193_001
2ANDA090842RALOXIFENE HYDROCHLORIDEINVAGEN PHARMACEUTICALS INC2014-09-24ANDA090842_001
3ANDA200825RALOXIFENE HYDROCHLORIDEWATSON LABORATORIES INC2015-01-21ANDA200825_001
4ANDA204310RALOXIFENE HYDROCHLORIDEAUROBINDO PHARMA LTD2015-08-28ANDA204310_001
5NDA020815EVISTAELI LILLY AND CO1997-12-09p8030330, SUBSTANCE
p6797719, SUBSTANCE
p6458811, USE FOR PREVENTION OF BREAST CANCER, SUBSTANCE
p6894064, PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2014-09-13]NDA020815_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078193_001RXRALOXIFENE HYDROCHLORIDE (60MG)ORALTABLETFalseAB2014-03-04RALOXIFENE HYDROCHLORIDE
2ANDA090842_001RXRALOXIFENE HYDROCHLORIDE (60MG)ORALTABLETFalseAB2014-09-24RALOXIFENE HYDROCHLORIDE
3ANDA200825_001RXRALOXIFENE HYDROCHLORIDE (60MG)ORALTABLETFalseAB2015-01-21RALOXIFENE HYDROCHLORIDE
4ANDA204310_001RXRALOXIFENE HYDROCHLORIDE (60MG)ORALTABLETFalseAB2015-08-28RALOXIFENE HYDROCHLORIDE
5NDA020815_001RXRALOXIFENE HYDROCHLORIDE (60MG)ORALTABLETTrueAB1997-12-09EVISTA

patent(s)

#idexpiration dateapplication(s)
1p6458811 (view patent)2017-03-10NDA020815
2p6797719 (view patent)2017-03-10NDA020815
3p6894064 (view patent)2017-03-10NDA020815
4p8030330 (view patent)2017-03-10NDA020815

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
101143c04-f5d7-481d-95bb-d384f2413585 (view SPL)These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA.EVISTA (raloxifene hydrochloride) Tablet for Oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-05-211548684170
213a872e6-8983-5085-e3d5-8ebcdb6d213e (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride tablets USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets USP. RALOXIFENE hydrochloride tablets USP for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionAvkare, Inc.2015-08-052422910726
32b94ecf5-d870-4132-b455-d5ee5c9dce56 (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997prescriptionHuman PrescriptionExelan Pharmaceuticals Inc.analysis, manufacture2014-11-121762820256
43385dd3d-c096-4957-8ba2-d91630f655ea (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride safely and effectively. See full prescribing information for raloxifene hydrochloride.Raloxifene Hydrochloride Tablet for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionPrasco Laboratories2015-04-032669930417
544c89f9c-2194-4d33-9bde-f8f309d33ef2 (view SPL)These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, USPsafely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS, USP.RALOXIFENE HYDROCHLORIDE tablets, USPfor oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionPrasco LaboratoriesANALYSIS, API MANUFACTURE, MANUFACTURE2015-09-021669930661
65982304f-50fa-468b-9982-6e18d356ed01 (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride safely and effectively. See full prescribing information for raloxifene hydrochloride.Raloxifene Hydrochloride Tablet for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-051691890418
77f4bd906-2af7-4f93-af23-6f13b0f5d868 (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionAmerican Health PackagingREPACK2014-11-201680840871
88f4fe353-c5de-44ba-9c68-b75a185f7dc5 (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionCamber Pharmaceuticals, Inc.manufacture2014-09-241317220256
9be68ba7b-19fc-49b0-b9a7-685b11bc0fe0 (view SPL)These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA.EVISTA (raloxifene hydrochloride) Tablet for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-02-2312552890266
10cbee500a-34e2-4819-987b-da107eacbb27 (view SPL)These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA.EVISTA (raloxifene hydrochloride) Tablet for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel2012-03-073626499990458
11d7282df8-9637-40f7-9004-7198918606a9 (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride safely and effectively. See full prescribing information for raloxifene hydrochloride.Raloxifene Hydrochloride Tablet for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionKaiser Foundations Hospitalsrepack2014-06-032001790151
12e6be5b1d-757d-4bab-ad6a-c421960a104d (view SPL)These highlights do not include all the information needed to use raloxifene hydrochloride tablets USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets USP. RALOXIFENE hydrochloride tablets USP for oral use Initial U.S. Approval: 1997prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-11-043000937290
13e8b6cbe0-c1f4-4678-b852-f629a7f6a1b5 (view SPL)These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS, USPsafely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS, USP.RALOXIFENE HYDROCHLORIDE tablets, USPfor oral useInitial U.S. Approval: 1997prescriptionHuman PrescriptionAurobindo Pharma LimitedANALYSIS, API MANUFACTURE, MANUFACTURE2015-08-281658620709
14f9eeef29-f34d-4261-b8c3-499f31365b33 (view SPL)These highlights do not include all the information needed to use Raloxifene Hydrochloride tablets safely and effectively. See full prescribing information for Raloxifene Hydrochloride tablets. Raloxifene HydrochlorideTablets, USP for Oral Use Initial U.S. Approval: 1997prescriptionHuman PrescriptionWatson Laboratories, Inc.2014-07-019005912367
15fcaaa6dc-74e8-4fb8-800c-5574bf0f8de9 (view SPL)These highlights do not include all the information needed to use EVISTA safely and effectively. See full prescribing information for EVISTA.EVISTA (raloxifene hydrochloride) Tablet for Oral UseInitial U.S. Approval: 1997prescriptionHuman PrescriptionEli Lilly And Company2015-02-0917000024165

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