FDA.reportPublic FDA data

Application 761037

Type
BLA
Sponsor
SANOFI SYNTHELABO

Application Products#

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

NDC Listings For This Application#

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