tedizolid Oral Tablet

Brand(s)
Sivextro
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-07-28)
Oldest Current Product
2014-06-20
License(s)
NDA
RxNORM
ORAL TABLET\TEDIZOLID
FDAOB
ORAL\TABLET\TEDIZOLID PHOSPHATE
SPL Active
ORAL\TABLET, FILM COATED\TEDIZOLID PHOSPHATE
SPL Moiety
ORAL\TABLET, FILM COATED\TEDIZOLID

product(s) by strength(s)

tedizolid phosphate 200 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1679190041SivextroNDAMerck Sharp & Dohme Corp.2014-06-20TEDIZOLID PHOSPHATEORALTABLET, FILM COATEDNDA20543575672079-589f-451a-bdbf-eaebcfcc80a9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205435SIVEXTROCUBIST PHARMACEUTICALS LLC2014-06-20p8426389, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p8420676, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p7816379, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
Generating Antibiotic Incentives Now [2024-06-20]
NEW CHEMICAL ENTITY [2019-06-20]
NDA205435_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205435_001RXTEDIZOLID PHOSPHATE (200MG)ORALTABLETTrue2014-06-20SIVEXTRO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7816379 (view patent)2028-02-23NDA205435, NDA205436tedizolid Injectable Solution
2p8420676 (view patent)2028-02-23NDA205435, NDA205436tedizolid Injectable Solution
3p8426389 (view patent)2030-12-31NDA205435, NDA205436tedizolid Injectable Solution

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)in other drug docs
175672079-589f-451a-bdbf-eaebcfcc80a9 (view SPL)These highlights do not include all the information needed to use SIVEXTRO safely and effectively. See full prescribing information for SIVEXTRO. SIVEXTRO (tedizolid phosphate) for injection, for intravenous use SIVEXTRO (tedizolid phosphate) tablet, for oral use Initial U.S. Approval: 2014prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-07-286679190041, 679190040tedizolid Injectable Solution

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