Calcium Chloride / icodextrin / Lactate / Magnesium Chloride / Sodium Chloride Injectable Solution

Brand(s)
Extraneal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2015-10-16)
Oldest Current Product
2002-12-20
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\CALCIUM CHLORIDE:ICODEXTRIN:LACTATE:MAGNESIUM CHLORIDE:SODIUM CHLORIDE
FDAOB
INTRAPERITONEAL\SOLUTION\ICODEXTRIN
SPL Active
INTRAPERITONEAL\INJECTION, SOLUTION\CALCIUM CHLORIDE: ICODEXTRIN: MAGNESIUM CHLORIDE: SODIUM CHLORIDE: SODIUM LACTATE
SPL Moiety
INTRAPERITONEAL\INJECTION, SOLUTION\CHLORIDE ION: ICODEXTRIN: LACTIC ACID, UNSPECIFIED FORM

product(s) by strength(s)

calcium chloride 0.00232 meq/ml / icodextrin 75 mg/ml / magnesium chloride 0.000533 meq/ml / sodium chloride 0.0915 meq/ml / sodium lactate 0.04 meq/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1009410679ExtranealNDABaxter Healthcare Corporation2002-12-20CALCIUM CHLORIDE, ICODEXTRIN, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATEINTRAPERITONEALINJECTION, SOLUTIONNDA021321d5b85158-b0d6-4855-9d07-8d1b3ad9ab71

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021321EXTRANEALBAXTER HEALTHCARE CORP2002-12-20p6248726, PERITONEAL DIALYSIS SOLUTION
p6077836, PERITONEAL DIALYSIS SOLUTION
NDA021321_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021321_001RXICODEXTRIN (7.5GM/100ML)INTRAPERITONEALSOLUTIONTrue2002-12-20EXTRANEAL

patent(s)

#idexpiration dateapplication(s)
1p6077836 (view patent)2017-06-20NDA021321
2p6248726 (view patent)2018-06-19NDA021321

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1d5b85158-b0d6-4855-9d07-8d1b3ad9ab71 (view SPL)These highlights do not include all the information needed to use EXTRANEAL safely and effectively. See full prescribing information for EXTRANEAL. EXTRANEAL (icodextrin) peritoneal dialysis solutionInitial U.S. Approval: 2002prescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, STERILIZE2015-10-1612009410679

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