bazedoxifene / Estrogens, Conjugated (USP) Oral Tablet

Brand(s)
Duavee
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Wyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc. (2015-11-10)
Oldest Current Product
2013-10-03
License(s)
NDA
RxNORM
ORAL TABLET\BAZEDOXIFENE:ESTROGENS, CONJUGATED (USP)
FDAOB
ORAL\TABLET\BAZEDOXIFENE ACETATE: ESTROGENS, CONJUGATED
SPL Active
ORAL\TABLET, FILM COATED\BAZEDOXIFENE ACETATE: ESTROGENS, CONJUGATED
SPL Moiety
ORAL\TABLET, FILM COATED\BAZEDOXIFENE: ESTROGENS, CONJUGATED

product(s) by strength(s)

bazedoxifene 20 mg / estrogens, conjugated (usp) 0.45 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000081123DuaveeNDAWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.2013-10-03BAZEDOXIFENE ACETATE, ESTROGENS, CONJUGATEDORALTABLET, FILM COATEDNDA022247e1b75458-2e5b-46b9-92c6-fa6daba3770f
2635390122DuaveeNDAU.S. Pharmaceuticals2013-11-15BAZEDOXIFENE ACETATE, ESTROGENS, CONJUGATEDORALTABLET, FILM COATEDNDA022247e16705d8-4472-4f83-96ac-69fa2be066cb

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022247DUAVEEWYETH PHARMACEUTICALS INC WHOLLY OWNED SUB PFIZER INC2013-10-03p7138392, PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS, SUBSTANCE
p7683051, TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE/ PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS, SUBSTANCE
p6479535, TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE/ PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS, SUBSTANCE
p5998402, PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS, SUBSTANCE
p8815934, SUBSTANCE
NEW PRODUCT [2016-10-03]NDA022247_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022247_001RXESTROGENS, CONJUGATED (0.45MG), BAZEDOXIFENE ACETATE (EQ 20MG BASE)ORALTABLETTrue2013-10-03DUAVEE

patent(s)

#idexpiration dateapplication(s)
1p5998402 (view patent)2017-04-04NDA022247
2p6479535 (view patent)2019-05-06NDA022247
3p7138392 (view patent)2017-04-04NDA022247
4p7683051 (view patent)2027-03-10NDA022247
5p8815934 (view patent)2019-05-06NDA022247

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1bfdd5d5b-7569-4848-afa2-e820fbe3c8fb (view SPL)These highlights do not include all the information needed to use DUAVEE safely and effectively. See full prescribing information for DUAVEE. DUAVEE (conjugated estrogens/bazedoxifene) tablets for oral use Initial U.S. approval: 2013prescriptionHuman PrescriptionU.S. PharmaceuticalsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-11-061635390112
2e16705d8-4472-4f83-96ac-69fa2be066cb (view SPL)These highlights do not include all the information needed to use DUAVEE safely and effectively. See full prescribing information for DUAVEE. DUAVEE (conjugated estrogens/bazedoxifene) tablets for oral use Initial U.S. approval: 2013prescriptionHuman PrescriptionU.S. PharmaceuticalsANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-11-152635390122
3e1b75458-2e5b-46b9-92c6-fa6daba3770f (view SPL)These highlights do not include all the information needed to use DUAVEE safely and effectively. See full prescribing information for DUAVEE. DUAVEE (conjugated estrogens/bazedoxifene) tablets for oral use Initial U.S. approval: 2013prescriptionHuman PrescriptionWyeth Pharmaceuticals Inc., A Subsidiary Of Pfizer Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-11-107000081123

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