Clozapine Oral Suspension

Brand(s)
Versacloz
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Jazz Pharmaceuticals, Inc. (2015-09-30)
Oldest Current Product
2013-02-15
License(s)
NDA
RxNORM
ORAL SUSPENSION\CLOZAPINE
FDAOB
ORAL\SUSPENSION\CLOZAPINE
SPL Active
ORAL\SUSPENSION\CLOZAPINE
SPL Moiety
ORAL\SUSPENSION\CLOZAPINE

product(s) by strength(s)

clozapine 50 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1188600121VersaclozNDAJazz Pharmaceuticals, Inc.2013-02-15CLOZAPINEORALSUSPENSIONNDA203479693cb9d4-39db-4ecf-9eae-b01f06f8d5d1

application(s)

#idtitleapplicantapprovedapproved drug
1NDA203479VERSACLOZJAZZ PHARMACEUTICALS INTERNATIONAL III2013-02-06NDA203479_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203479_001RXCLOZAPINE (50MG/ML)ORALSUSPENSIONTrue2013-02-06VERSACLOZ

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1693cb9d4-39db-4ecf-9eae-b01f06f8d5d1 (view SPL)These highlights do not include all the information needed to use VERSACLOZ safely and effectively. See full prescribing information for VERSACLOZ. VERSACLOZ (clozapine) oral suspensionInitial U.S. Approval: 1989prescriptionHuman PrescriptionJazz Pharmaceuticals, Inc.MANUFACTURE, PACK2015-09-308188600121

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