Sincalide Injectable Solution

Brand(s)
Kinevac
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bracco Diagnostics Inc. (2015-07-13)
Oldest Current Product
1976-07-21
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\SINCALIDE
FDAOB
INJECTION\INJECTION\SINCALIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\SINCALIDE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\SINCALIDE

product(s) by strength(s)

sincalide 0.001 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002700556KinevacNDABracco Diagnostics Inc.1976-07-21SINCALIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0176971408aabb-6982-48e5-ae9f-504ec43b0003

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840556KinevacNDAGeneral Injecatables & Vaccines, Inc2010-11-05SINCALIDEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION002700556NDA017697d7f3d501-a389-4fe1-b20a-c9665b3f3d37

application(s)

#idtitleapplicantpatentapproved drug
1NDA017697KINEVACBRACCO DIAGNOSTICS INCp6803046, SUBSTANCENDA017697_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapplication
1NDA017697_001RXSINCALIDE (0.005MG/VIAL)INJECTIONTrueKINEVAC

patent(s)

#idexpiration dateapplication(s)
1p6803046 (view patent)2022-08-16NDA017697

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11408aabb-6982-48e5-ae9f-504ec43b0003 (view SPL)KINEVAC Sincalide for InjectionprescriptionHuman PrescriptionBracco Diagnostics Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-07-134002700556
2d7f3d501-a389-4fe1-b20a-c9665b3f3d37 (view SPL)Kinevac 5mcgprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-11-051525840556

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