edoxaban Oral Tablet

Brand(s)
Savaysa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Daiichi Sankyo (2015-09-16)
Oldest Current Product
2015-01-12
License(s)
NDA
RxNORM
ORAL TABLET\EDOXABAN
FDAOB
ORAL\TABLET\EDOXABAN TOSYLATE
SPL Active
ORAL\TABLET, FILM COATED\EDOXABAN TOSYLATE
SPL Moiety
ORAL\TABLET, FILM COATED\EDOXABAN

product(s) by strength(s)

edoxaban 15 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1655970201SavaysaNDADaiichi Sankyo2015-01-12EDOXABAN TOSYLATEORALTABLET, FILM COATEDNDA206316e77d3400-56ad-11e3-949a-0800200c9a66

edoxaban 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1655970202SavaysaNDADaiichi Sankyo2015-01-12EDOXABAN TOSYLATEORALTABLET, FILM COATEDNDA206316e77d3400-56ad-11e3-949a-0800200c9a66

edoxaban 60 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1655970203SavaysaNDADaiichi Sankyo2015-01-12EDOXABAN TOSYLATEORALTABLET, FILM COATEDNDA206316e77d3400-56ad-11e3-949a-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206316SAVAYSADAIICHI SANKYO INC2015-01-08p7365205NEW CHEMICAL ENTITY [2020-01-08]NDA206316_001, NDA206316_002, NDA206316_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206316_001RXEDOXABAN TOSYLATE (EQ 15MG BASE)ORALTABLETFalse2015-01-08SAVAYSA
2NDA206316_002RXEDOXABAN TOSYLATE (EQ 30MG BASE)ORALTABLETFalse2015-01-08SAVAYSA
3NDA206316_003RXEDOXABAN TOSYLATE (EQ 60MG BASE)ORALTABLETTrue2015-01-08SAVAYSA

patent(s)

#idexpiration dateapplication(s)
1p7365205 (view patent)2023-06-12NDA206316

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1e77d3400-56ad-11e3-949a-0800200c9a66 (view SPL)These highlights do not include all the information needed to use SAVAYSA safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA (edoxaban) tablets for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionDaiichi Sankyo2015-09-166655970201, 655970202, 655970203

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