FDA.reportPublic FDA data

Application 761037

Type
BLA
Sponsor
SANOFI SYNTHELABO

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761037Kevzarasarilumab351(a)Rx2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KEVZARASARILUMABINJECTABLE;INJECTION150MG/1.14MLYesNo
002KEVZARASARILUMABINJECTABLE;INJECTION200MG/1.14MLYesNo

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
KEVZARASARILUMABSanofi-Aventis U.S. LLC827bc01c-d379-4266-a18c-c7f904b76af32026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761037
ndc (product): 0024-5922
ndc (product): 0024-5920
ndc (product): 0024-5908
ndc (product): 0024-5910

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5908KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5908KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5908KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5908KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5910KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5910KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5910KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5910KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5920KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5920KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5920KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5920KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5922KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5922KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5922KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent
0024-5922KEVZARAsarilumabsanofi-aventis U.S. LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78769SUPPL 2024-06-12
78768SUPPL 2024-06-12
78767SUPPL 2024-06-11
73648SUPPL 2023-03-01
73644SUPPL 2023-03-01
53692SUPPL2018-04-16
53670SUPPL2018-04-13
53669SUPPL2018-04-13
48887ORIG2017-07-03
48520ORIG2017-05-25
48518ORIG2017-05-24