lucinactant Injectable Suspension

Brand(s)
Surfaxin
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2013-11-01
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\LUCINACTANT
FDAOB
INTRATRACHEAL\SUSPENSION\LUCINACTANT\rdfq
SPL Active
ENDOTRACHEAL\SUSPENSION\1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)), SODIUM SALT: COLFOSCERIL PALMITATE: PALMITIC ACID: SINAPULTIDE
SPL Moiety
ENDOTRACHEAL\SUSPENSION\1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)): COLFOSCERIL PALMITATE: PALMITIC ACID: SINAPULTIDE

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1686280500SurfaxinNDADiscovery Laboratories, Inc.2013-11-011-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)), SODIUM SALT, COLFOSCERIL PALMITATE, PALMITIC ACID, SINAPULTIDEENDOTRACHEALSUSPENSIONNDA021746f2ba0c81-ceb0-11e0-9572-0800200c9a66

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1NDA021746SURFAXINTrueDISCOVERY LABORATORIES INC2012-03-06p5407914, PREVENTION OF RESPIRATORY DISTRESS (RDS) IN PREMATURE INFANTS, SUBSTANCENDA021746_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA021746_001discontinuedLUCINACTANT (8.5ML)SUSPENSIONFalse2012-03-06SURFAXIN

patent(s)

#idexpiration dateapplication(s)
1p5407914 (view patent)2014-11-17NDA021746

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f2ba0c81-ceb0-11e0-9572-0800200c9a66 (view SPL)These highlights do not include all the information needed to use SURFAXIN safely and effectively. See full prescribing information for SURFAXIN. SURFAXIN (lucinactant) Intratracheal Suspension Initial U.S. Approval: 2012prescriptionHuman PrescriptionDiscovery Laboratories, Inc.MANUFACTURE2014-04-259686280500

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