ceftolozane / tazobactam Injection

Brand(s)
Zerbaxa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-10-14)
Oldest Current Product
2014-12-19
License(s)
NDA
RxNORM
INJECTION\CEFTOLOZANE:TAZOBACTAM
FDAOB
IV (INFUSION)\POWDER\CEFTOLOZANE SULFATE: TAZOBACTAM SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CEFTOLOZANE SULFATE: TAZOBACTAM SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CEFTOLOZANE: TAZOBACTAM

product(s) by strength(s)

ceftolozane 1000 mg / tazobactam 500 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1679190030ZerbaxaNDAMerck Sharp & Dohme Corp.2014-12-19CEFTOLOZANE SULFATE, TAZOBACTAM SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA20682970ac1d90-eff3-4f0b-9f46-5846c571b32f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206829ZERBAXACUBIST PHARMACEUTICALS LLC2014-12-19p7129232, METHODS OF TREATING BACTERIAL ILLNESSES, SUBSTANCE
p8476425
p8685957, METHODS OF TREATING BACTERIAL ILLNESSES
p8968753, TREATMENT OF COMPLICATED URINARY TRACT INFECTION/ TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION
p8906898, SUBSTANCE
NEW CHEMICAL ENTITY [2019-12-19]
Generating Antibiotic Incentives Now [2024-12-19]
NDA206829_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA206829_001RXCEFTOLOZANE SULFATE (EQ 1GM BASE/VIAL), TAZOBACTAM SODIUM (EQ 0.5GM BASE/VIAL)POWDERTrue2014-12-19ZERBAXA

patent(s)

#idexpiration dateapplication(s)
1p7129232 (view patent)2024-10-21NDA206829
2p8476425 (view patent)2032-09-27NDA206829
3p8685957 (view patent)2032-09-27NDA206829
4p8906898 (view patent)2034-05-28NDA206829
5p8968753 (view patent)2034-03-14NDA206829

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
170ac1d90-eff3-4f0b-9f46-5846c571b32f (view SPL)These highlights do not include all the information needed to use ZERBAXA safely and effectively. See full prescribing information for ZERBAXA. ZERBAXA (ceftolozane and tazobactam) for injection, for intravenous useInitial U.S. Approval: 2014prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.2015-10-144679190030

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