FDA.reportPublic FDA data

Application 761049

Type
BLA
Sponsor
EMD SERONO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BAVENCIOAVELUMABINJECTABLE;INJECTION20MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44087-3535BAVENCIOavelumabEMD Serono, Inc.BLACurrent
44087-3535BAVENCIOavelumabEMD Serono, Inc.BLACurrent
44087-3535BAVENCIOavelumabEMD Serono, Inc.BLACurrent
44087-3535BAVENCIOavelumabEMD Serono, Inc.BLACurrent
44087-3535BAVENCIOavelumabEMD Serono, Inc.BLACurrent
44087-3535BAVENCIOavelumabEMD Serono, Inc.BLACurrent
44087-3535BAVENCIOavelumabEMD Serono, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82472SUPPL 2025-06-06
82469SUPPL 2025-06-05
82467SUPPL 2025-06-05
80462SUPPL 2024-12-02
80461SUPPL 2024-12-02
80437SUPPL 2024-11-29
79905SUPPL 2024-10-15
79877SUPPL 2024-10-14
77786SUPPL 2024-03-12
77784SUPPL 2024-03-12
77763SUPPL 2024-03-08
75368SUPPL 2023-09-07
75362SUPPL 2023-09-07
71598SUPPL2022-07-19
71597SUPPL2022-07-19
71583SUPPL2022-07-18
65209SUPPL2020-11-13
65208SUPPL2020-11-13
65189SUPPL2020-11-12
65153SUPPL2020-11-04
63775SUPPL2020-07-01
63763SUPPL2020-07-01
63762SUPPL2020-07-01
58730SUPPL2019-05-15
58713SUPPL2019-05-15
58712SUPPL2019-05-15
56125SUPPL2018-10-26
56077SUPPL2018-10-23
50215SUPPL2017-10-30
50178SUPPL2017-10-25
48227ORIG2017-05-02
48150SUPPL2017-04-27
47662ORIG2017-03-24
47651ORIG2017-03-23