FDA.reportPublic FDA data

Application 103946

Type
BLA
Sponsor
SANOFI SYNTHELABO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103946Elitekrasburicase351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELITEKRASBURICASEVIAL; INTRAVENOUS1.5MG/VIALNoNo

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ElitekRASBURICASESanofi-Aventis U.S. LLC0ae10bc4-6b65-402f-9db5-2d77530549222026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103946
ndc (product): 0024-5150
ndc (product): 0024-5151

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5150Elitekrasburicasesanofi-aventis U.S. LLCBLACurrent
0024-5150ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5150ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5150ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5151ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5151ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent
0024-5151ElitekrasburicaseSanofi-Aventis U.S. LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61272SUPPL2019-12-13
61263SUPPL2019-12-13
49778SUPPL2017-09-19
49759SUPPL2017-09-18
39735SUPPL2016-06-17
31696SUPPL2016-06-15
39734SUPPL2015-05-27
31695SUPPL2015-05-26
9493SUPPL2015-02-12
31694SUPPL2009-10-26
39733SUPPL2009-10-19
31693SUPPL2007-10-04
18673SUPPL2007-10-04
39732SUPPL2005-01-26
9492SUPPL2005-01-26
43292ORIG2004-03-12
39731ORIG2004-03-12
9491ORIG2004-03-12