SAMARIUM Sm153 Injectable Solution

Brand(s)
Quadramet
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Jazz Pharmaceuticals, Inc. (2013-01-28)
Oldest Current Product
1997-05-19
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\SAMARIUM SM153
FDAOB
INJECTION\INJECTION\SAMARIUM SM-153 LEXIDRONAM PENTASODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\SAMARIUM SM-153

product(s) by strength(s)

samarium sm153 50 mci/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1579020860QuadrametNDAJazz Pharmaceuticals, Inc.1997-05-19SAMARIUM SM-153 LEXIDRONAM PENTASODIUMINTRAVENOUSINJECTION, SOLUTIONNDA02057089cae12d-05fc-4d53-920f-e271b2940a5d

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020570QUADRAMETLANTHEUS MEDICAL IMAGING INC1997-03-28NDA020570_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA020570_001RXSAMARIUM SM-153 LEXIDRONAM PENTASODIUM (50mCi/ML)INJECTIONTrue1997-03-28QUADRAMET

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
161e84808-0999-4923-910c-2a480d5f971a (view SPL)QUADRAMET Prescribing Information QUADRAMET (SAMARIUM SM 153 LEXIDRONAM INJECTION) 513145-1213 December 2013 Therapeutic - For Intravenous AdministrationprescriptionHuman PrescriptionLantheus Medical Imaging, Inc.LABEL, MANUFACTURE, PACK2013-12-181119940016
289cae12d-05fc-4d53-920f-e271b2940a5d (view SPL)QUADRAMET Prescribing Information QUADRAMET (SAMARIUM SM 153 LEXIDRONAM INJECTION) May 2009 Therapeutic - For Intravenous AdministrationprescriptionHuman PrescriptionJazz Pharmaceuticals, Inc.2013-01-284579020860

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