tedizolid Injectable Solution

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
INJECTABLE SOLUTION\TEDIZOLID
FDAOB
IV (INFUSION)\POWDER\TEDIZOLID PHOSPHATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TEDIZOLID PHOSPHATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TEDIZOLID

product(s) by strength(s)

tedizolid phosphate 50 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1679190040SivextroNDAMerck Sharp & Dohme Corp.2014-06-20TEDIZOLID PHOSPHATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA20543675672079-589f-451a-bdbf-eaebcfcc80a9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205436SIVEXTROCUBIST PHARMACEUTICALS LLC2014-06-20p8426389, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p8420676, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
p7816379, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
NEW CHEMICAL ENTITY [2019-06-20]
Generating Antibiotic Incentives Now [2024-06-20]
NDA205436_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA205436_001RXTEDIZOLID PHOSPHATE (200MG/VIAL)POWDERTrue2014-06-20SIVEXTRO

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7816379 (view patent)2028-02-23NDA205436, NDA205435tedizolid Oral Tablet
2p8420676 (view patent)2028-02-23NDA205436, NDA205435tedizolid Oral Tablet
3p8426389 (view patent)2030-12-31NDA205436, NDA205435tedizolid Oral Tablet

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.2015-07-286679190040, 679190041tedizolid Oral Tablet

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