FDA.reportPublic FDA data

Application 761113

Type
BLA
Sponsor
SANOFI AVENTIS US

Application Products#

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

NDC Listings For This Application#

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