FDA.reportPublic FDA data

Application 761113

Type
BLA
Sponsor
SANOFI AVENTIS US

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761113Sarclisaisatuximab-irfc351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SARCLISAISATUXIMAB-IRFCINJECTABLE;INJECTION100MG/5ML (20MG/ML)NoNo
002SARCLISAISATUXIMAB-IRFCINJECTABLE;INJECTION500MG/25ML (20MG/ML)NoNo

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
SarclisaISATUXIMABSanofi-Aventis U.S. LLCa0473462-6f9d-4eca-a5bf-8620aea68e8a2026-07-07Warnings, Adverse reactionsExact identifier
application number: BLA761113
ndc (product): 0024-0656
ndc (product): 0024-0654

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-0654Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent
0024-0654Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent
0024-0654Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent
0024-0654Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent
0024-0656Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent
0024-0656Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent
0024-0656Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent
0024-0656Sarclisaisatuximabsanof-aventis U.S. LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80034SUPPL 2024-10-29
80033SUPPL 2024-10-29
80029SUPPL 2024-10-28
80028SUPPL 2024-10-28
79722SUPPL 2024-09-24
79674SUPPL 2024-09-20
76036SUPPL 2023-11-02
76033SUPPL 2023-11-02
71596SUPPL2022-07-19
71584SUPPL2022-07-18
66939SUPPL2021-04-01
66935SUPPL2021-03-31
66816SUPPL2021-03-19
66813SUPPL2021-03-19
62313ORIG2020-03-25
62020ORIG2020-03-04
62005ORIG2020-03-02