Estradiol Vaginal Tablet

Brand(s)
Vagifem
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novo Nordisk (2014-10-30)
Oldest Current Product
2010-01-11
License(s)
NDA, ANDA
RxNORM
VAGINAL TABLET\ESTRADIOL
FDAOB
VAGINAL\TABLET\ESTRADIOL
SPL Active
VAGINAL\TABLET, FILM COATED\ESTRADIOL
VAGINAL\TABLET\ESTRADIOL
SPL Moiety
VAGINAL\TABLET, FILM COATED\ESTRADIOL
VAGINAL\TABLET\ESTRADIOL

product(s) by strength(s)

estradiol 0.01 mg vaginal tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001695176VagifemNDANovo Nordisk2010-01-11ESTRADIOLVAGINALTABLET, FILM COATEDNDA020908e5ad3cf6-dd96-4e64-af21-c1eee38d0b88

invalid application product(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1651620226ANDAAmneal Pharmaceuticals2015-06-07ESTRADIOLVAGINALTABLETANDA20525630c7f6ba-7a9e-4853-b3e4-e00a46560224

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548686182VagifemNDAPhysicians Total Care, Inc.2010-09-24ESTRADIOLVAGINALTABLET, FILM COATED001695176NDA020908d67888ac-5041-4758-88db-845a41f67df4

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA205256ESTRADIOLTrueAMNEAL PHARMACEUTICALS2015-05-29ANDA205256_001
2NDA020908VAGIFEMNOVO NORDISK INC1999-03-26p5860946, SUBSTANCE
p7018992, TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
NDA020908_001, NDA020908_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA205256_001discontinuedESTRADIOL (10MCG)VAGINALTABLETFalse2015-05-29ESTRADIOL
2NDA020908_001discontinuedESTRADIOL (25MCG)VAGINALTABLETFalse1999-03-26VAGIFEM
3NDA020908_002RXESTRADIOL (10MCG)VAGINALTABLETTrue2009-11-25VAGIFEM

patent(s)

#idexpiration dateapplication(s)
1p5860946 (view patent)2017-07-01NDA020908
2p7018992 (view patent)2022-09-17NDA020908

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
130c7f6ba-7a9e-4853-b3e4-e00a46560224 (view SPL)These highlights do not include all the information needed to use Estradiol safely and effectively. See full prescribing information for Estradiol. Estradiol (Estradiol) TABLET for VAGINAL use.Initial U.S. Approval: 1999prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-01-015651620226
2d67888ac-5041-4758-88db-845a41f67df4 (view SPL)These highlights do not include all the information needed to use Vagifem safely and effectively. See full prescribing information for Vagifem.Vagifem (estradiol vaginal tablets)Initial U.S. Approval: 1999prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-03-152548686182
3e5ad3cf6-dd96-4e64-af21-c1eee38d0b88 (view SPL)These highlights do not include all the information needed to use VAGIFEM safely and effectively. See full prescribing information for VAGIFEM.Vagifem (estradiol vaginal tablets)Initial U.S. Approval: 1999prescriptionHuman PrescriptionNovo NordiskMANUFACTURE2014-10-3010001695176

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