oritavancin Injectable Solution

Brand(s)
Orbactiv
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
The Medicines Company (2014-09-08)
Oldest Current Product
2014-09-01
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\ORITAVANCIN
FDAOB
IV (INFUSION)\POWDER\ORITAVANCIN DIPHOSPHATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ORITAVANCIN
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\ORITAVANCIN

product(s) by strength(s)

oritavancin 1.2 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1652930015OrbactivNDAThe Medicines Company2014-09-01ORITAVANCININTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA206334085d6d1a-21c2-11e4-8c21-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206334ORBACTIVTHE MEDICINES CO2014-08-06p8420592, TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE
p5998581
p5840684, TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS, SUBSTANCE
NEW CHEMICAL ENTITY [2019-08-06]
Generating Antibiotic Incentives Now [2024-08-06]
NDA206334_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA206334_001RXORITAVANCIN DIPHOSPHATE (EQ 400MG BASE/VIAL)POWDERTrue2014-08-06ORBACTIV

patent(s)

#idexpiration dateapplication(s)
1p5840684 (view patent)2015-11-24NDA206334
2p5998581 (view patent)2017-11-12NDA206334
3p8420592 (view patent)2029-08-29NDA206334

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1085d6d1a-21c2-11e4-8c21-0800200c9a66 (view SPL)These highlights do not include all the information needed to use ORBACTIV safely and effectively. See full prescribing information for ORBACTIV. ORBACTIV (oritavancin) for injection, for intravenous use Initial U.S. Approval: 2014prescriptionHuman PrescriptionThe Medicines CompanyANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-09-082652930015

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