doripenem Injectable Suspension

Brand(s)
DORIBAX
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Shionogi Inc. (2015-08-11)
Oldest Current Product
2010-10-15
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\DORIPENEM
FDAOB
IV (INFUSION)\INJECTION\DORIPENEM\rdfq
SPL Active
INTRAVENOUS\POWDER, FOR SOLUTION\DORIPENEM
SPL Moiety
INTRAVENOUS\POWDER, FOR SOLUTION\DORIPENEM

product(s) by strength(s)

doripenem 25 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1596300309DORIBAXNDAShionogi Inc.2010-10-15DORIPENEMINTRAVENOUSPOWDER, FOR SOLUTIONNDA022106974cac49-7d08-4c2a-9c24-ce75f66d9d75

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1NDA022106DORIBAXSHIONOGI INC2007-10-12p8247402, SUBSTANCE
p5317016, METHOD OF TREATING BACTERIAL INFECTIONS, SUBSTANCE
NDA022106_001, NDA022106_002doripenem Injectable Solution

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA022106_001RXDORIPENEM (500MG/VIAL)INJECTIONTrue2007-10-12DORIBAX
2NDA022106_002RXDORIPENEM (250MG/VIAL)INJECTIONFalse2010-10-05DORIBAX

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p5317016 (view patent)2015-06-05NDA022106doripenem Injectable Solution
2p8247402 (view patent)2021-03-30NDA022106doripenem Injectable Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1974cac49-7d08-4c2a-9c24-ce75f66d9d75 (view SPL)These highlights do not include all the information needed to use DORIBAX safely and effectively. See full prescribing information for DORIBAX . DORIBAX (doripenem for injection ), for intravenous use Initial U.S. Approval: 2007prescriptionHuman PrescriptionShionogi Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE2015-08-118596300309, 596300320doripenem Injectable Solution

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