Diclofenac Injectable Solution

Brand(s)
Dyloject
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2015-01-14)
Oldest Current Product
2015-04-01
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\DICLOFENAC
FDAOB
INTRAVENOUS\SOLUTION\DICLOFENAC SODIUM
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\DICLOFENAC SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\DICLOFENAC

product(s) by strength(s)

diclofenac sodium 37.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004091068DylojectNDAHospira, Inc.2015-04-01DICLOFENAC SODIUMINTRAVENOUSINJECTION, SOLUTIONNDA022396dd089777-5479-457a-bc22-3e49d8ae15b1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022396DYLOJECTJAVELIN PHARMACEUTICALS INC A WHOLLY OWNED SUDSIDIARY OF HOSPIRA INC2014-12-23p8946292, MANAGEMENT OF PAIN
p6407079, SUBSTANCE
NEW PRODUCT [2017-12-23]NDA022396_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022396_001RXDICLOFENAC SODIUM (37.5MG/ML)INTRAVENOUSSOLUTIONTrue2014-12-23DYLOJECT

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6407079 (view patent)2019-06-18NDA022396, NDA020657, NDA020966Itraconazole Oral Solution
2p8946292 (view patent)2027-03-22NDA022396

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1dd089777-5479-457a-bc22-3e49d8ae15b1 (view SPL)These highlights do not include all the information needed to use Dyloject safely and effectively. See full prescribing information for Dyloject. Dyloject (diclofenac sodium) Injection, for intravenous use Initial U.S. Approval: 1988prescriptionHuman PrescriptionHospira, Inc.2015-01-141004091068

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