FDA.reportPublic FDA data

Application 761028

Type
BLA
Sponsor
AMGEN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MVASIBEVACIZUMAB-AWWBINJECTABLE; INJECTION100MG/4ML (25MG/ML)NoNo
002MVASIBEVACIZUMAB-AWWBINJECTABLE; INJECTION400MG/16ML (25MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-206MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent
55513-207MVASIbevacizumab-awwbAmgen IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73576SUPPL 2023-02-21
69325SUPPL2021-11-16
69316SUPPL2021-11-16
67136SUPPL2021-04-22
67125SUPPL2021-04-20
59180SUPPL2019-06-27
59168SUPPL2019-06-25
55957ORIG2018-10-16
49732ORIG2017-09-14
49729ORIG2017-09-14