Caspofungin Injectable Solution

Brand(s)
Cancidas
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2014-09-12)
Oldest Current Product
2001-01-26
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\CASPOFUNGIN
FDAOB
IV (INFUSION)\INJECTION\CASPOFUNGIN ACETATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CASPOFUNGIN ACETATE
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CASPOFUNGIN

product(s) by strength(s)

caspofungin 5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063822CancidasNDAMerck Sharp & Dohme Corp.2001-01-26CASPOFUNGIN ACETATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0212273bad23a6-09a6-4194-9182-093ed61bc71c

caspofungin 7 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000063823CancidasNDAMerck Sharp & Dohme Corp.2001-01-26CASPOFUNGIN ACETATEINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0212273bad23a6-09a6-4194-9182-093ed61bc71c

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021227CANCIDASMERCK AND CO INC2001-01-26p5514650, CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, SUBSTANCE
p6136783, CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE
p5952300, SUBSTANCE
NDA021227_001, NDA021227_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021227_001RXCASPOFUNGIN ACETATE (50MG/VIAL)INJECTIONTrue2001-01-26CANCIDAS
2NDA021227_002RXCASPOFUNGIN ACETATE (70MG/VIAL)INJECTIONTrue2001-01-26CANCIDAS

patent(s)

#idexpiration dateapplication(s)
1p5514650 (view patent)2015-01-26NDA021227
2p5952300 (view patent)2017-03-28NDA021227
3p6136783 (view patent)2017-03-28NDA021227

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13bad23a6-09a6-4194-9182-093ed61bc71c (view SPL)These highlights do not include all the information needed to use CANCIDAS safely and effectively. See full prescribing information for CANCIDAS. CANCIDAS (caspofungin acetate) for injection, for intravenous useInitial U.S. Approval: 2001prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2014-09-1220000063822, 000063823

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