FDA.reportPublic FDA data

Application 761034

Type
BLA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TECENTRIQATEZOLIZUMABINJECTABLE;INJECTION1200MG/20MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-917TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent
50242-918TECENTRIQatezolizumabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85999SUPPL 2026-05-21
85973SUPPL 2026-05-19
85964SUPPL 2026-05-19
85940SUPPL 2026-05-18
85904SUPPL 2026-05-13
84202SUPPL 2025-11-18
84190SUPPL 2025-11-18
83649SUPPL 2025-10-03
83144SUPPL 2025-08-20
83136SUPPL 2025-08-19
78255SUPPL 2024-04-25
78208SUPPL 2024-04-23
74252SUPPL 2023-05-15
74251SUPPL 2023-05-15
74245SUPPL 2023-05-15
74244SUPPL 2023-05-15
72864SUPPL2022-12-12
72857SUPPL2022-12-12
72856SUPPL2022-12-12
72786SUPPL2022-12-05
72785SUPPL2022-12-05
69966SUPPL2022-01-25
69965SUPPL2022-01-25
69960SUPPL2022-01-25
69075SUPPL2021-10-22
69038SUPPL2021-10-20
68960SUPPL2021-10-12
68959SUPPL2021-10-12
68910SUPPL2021-10-07
67077SUPPL2021-04-16
67076SUPPL2021-04-16
67055SUPPL2021-04-14
66292SUPPL2021-02-18
66291SUPPL2021-02-18
66290SUPPL2021-02-18
66289SUPPL2021-02-18
66288SUPPL2021-02-18
66287SUPPL2021-02-18
66274SUPPL2021-02-18
66273SUPPL2021-02-18
66272SUPPL2021-02-18
66271SUPPL2021-02-18
66270SUPPL2021-02-18
66269SUPPL2021-02-18
66268SUPPL2021-02-18
65834SUPPL2021-01-06
65728SUPPL2020-12-23
65727SUPPL2020-12-23
65726SUPPL2020-12-23
65724SUPPL2020-12-23
65684SUPPL2020-12-22
65683SUPPL2020-12-22
65220SUPPL2020-11-13
65219SUPPL2020-11-13
65188SUPPL2020-11-12
64815SUPPL2020-10-02
64814SUPPL2020-10-02
64785SUPPL2020-10-01
64154SUPPL2020-07-31
64150SUPPL2020-07-30
63388SUPPL2020-06-02
63353SUPPL2020-05-29
63352SUPPL2020-05-29
63106SUPPL2020-05-19
63085SUPPL2020-05-18
61146SUPPL2019-12-04
61140SUPPL2019-12-03
61139SUPPL2019-12-03
58612SUPPL2019-05-08
58611SUPPL2019-05-08
58587SUPPL2019-05-07
58585SUPPL2019-05-07
58070SUPPL2019-03-25
58028SUPPL2019-03-19
56826SUPPL2019-03-12
57938SUPPL2019-03-08
57936SUPPL2019-03-08
56640SUPPL2018-12-06
54851SUPPL2018-07-06
54797SUPPL2018-07-06
54739SUPPL2018-07-02
54720SUPPL2018-06-28
54667SUPPL2018-06-21
54649SUPPL2018-06-21
54633SUPPL2018-06-20
54614SUPPL2018-06-20
54008SUPPL2018-05-03
53999SUPPL2018-05-03
52989SUPPL2018-03-15
52965SUPPL2018-03-14
48094SUPPL2017-04-24
43552ORIG2016-06-21
24538ORIG2016-06-21
10662ORIG2016-05-19
40639ORIG2016-05-18