Poractant alfa Injectable Suspension

Brand(s)
Curosurf
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Chiesi Usa, Inc. (2015-04-13)
Oldest Current Product
1999-11-18
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\PORACTANT ALFA
FDAOB
INTRATRACHEAL\SUSPENSION\PORACTANT ALFA\rdfq
SPL Active
ENDOTRACHEAL\SUSPENSION\PORACTANT ALFA
SPL Moiety
ENDOTRACHEAL\SUSPENSION\PORACTANT ALFA

product(s) by strength(s)

poractant alfa 80 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1101220510CurosurfNDAChiesi Usa, Inc.1999-11-18PORACTANT ALFAENDOTRACHEALSUSPENSIONNDA02074499bef307-00bd-4379-9f45-ede1380e74d4

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020744CUROSURFCHIESI USA INC1999-11-18NDA020744_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020744_001RXPORACTANT ALFA (80MG/ML)SUSPENSIONTrue1999-11-18CUROSURF

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
199bef307-00bd-4379-9f45-ede1380e74d4 (view SPL)These highlights do not include all the information needed to use CUROSURFsafely and effectively. See full prescribing information for CUROSURF. CUROSURF (poractant alfa)intratracheal suspension Initial U.S. Approval: 1999prescriptionHuman PrescriptionChiesi Usa, Inc.2015-04-1334101220510

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