Application 761034

Type
BLA
Sponsor
GENENTECH INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761034Tecentriqatezolizumab351(a)Rx2026-07-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TECENTRIQATEZOLIZUMABGenentech, Inc.6fa682c9-a312-4932-9831-f286908660ee2026-05-20Warnings, Adverse reactionsExact identifier
application number: BLA761034
ndc (product): 50242-918
ndc (product): 50242-917

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

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