dalbavancin Injectable Solution

Brand(s)
Dalvance
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Durata Therapeutics Inc. (2014-06-26)
Oldest Current Product
2014-05-23
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\DALBAVANCIN
FDAOB
IV (INFUSION)\INJECTION\DALBAVANCIN HYDROCHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\DALBAVANCIN HYDROCHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\DALBAVANCIN

product(s) by strength(s)

dalbavancin 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1579700100DalvanceNDADurata Therapeutics Inc.2014-05-23DALBAVANCIN HYDROCHLORIDEINTRAVENOUSINJECTION, POWDER, FOR SOLUTIONNDA0218834b4674d8-4d1e-4728-8465-d42ada33fa5c

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA021883DALVANCEDURATA THERAPEUTICS INTERNATIONAL BV2014-05-23p8143212, TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
p6900175, TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
p7115564, SUBSTANCE
p7119061, SUBSTANCE
NEW CHEMICAL ENTITY [2019-05-23]
Generating Antibiotic Incentives Now [2024-05-23]
NDA021883_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021883_001RXDALBAVANCIN HYDROCHLORIDE (EQ 500MG BASE/VIAL)INJECTIONTrue2014-05-23DALVANCE

patent(s)

#idexpiration dateapplication(s)
1p6900175 (view patent)2023-12-25NDA021883
2p7115564 (view patent)2023-11-14NDA021883
3p7119061 (view patent)2023-11-14NDA021883
4p8143212 (view patent)2023-11-14NDA021883

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14b4674d8-4d1e-4728-8465-d42ada33fa5c (view SPL)These highlights do not include all the information needed to use DALVANCE safely and effectively. See full prescribing information for DALVANCE. DALVANCE (dalbavancin) for injection, for intravenous use Initial U.S. Approval: 2014prescriptionHuman PrescriptionDurata Therapeutics Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-06-2612579700100

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