sargramostim Injectable Solution

Brand(s)
Leukine
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Genzyme Corporation (2013-08-02)
Oldest Current Product
2010-03-15
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\SARGRAMOSTIM
SPL Active
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\SARGRAMOSTIM
INTRAVENOUS\LIQUID\SARGRAMOSTIM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\SARGRAMOSTIM
INTRAVENOUS\LIQUID\SARGRAMOSTIM

product(s) by strength(s)

sargramostim 0.25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1584680180LeukineBLAGenzyme Corporation2010-03-152016-06-30SARGRAMOSTIMINTRAVENOUSINJECTION, POWDER, FOR SOLUTION103362c96afe62-f0cf-4d4b-b57d-194a8ec12389

sargramostim 0.5 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1584680181LeukineBLAGenzyme Corporation2010-03-152013-12-31SARGRAMOSTIMINTRAVENOUSLIQUID103362c96afe62-f0cf-4d4b-b57d-194a8ec12389

application(s)

#idtitleapprovedtradenamesfda division
1103362sargramostim Application1991-03-05LeukineCDER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104765fbf-f005-43aa-a628-5cc3d80f91e7 (view SPL)Leukine (sargramostim)prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK, RELABEL, REPACK2013-11-264000245843, 000245844
2c96afe62-f0cf-4d4b-b57d-194a8ec12389 (view SPL)leukine (sargramostim)prescriptionHuman PrescriptionGenzyme Corporationanalysis, label, manufacture, pack, relabel, repack2013-08-023584680180, 584680181

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