FDA.reportPublic FDA data

Application 125472

Type
BLA
Sponsor
GENENTECH

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125472Actemratocilizumab351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACTEMRATOCILIZUMABINJECTABLE;INTRAVENOUS, SUBCUTANEOUS162MG/0.9MLNoNo

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
ACTEMRATOCILIZUMABGenentech, Inc.2e5365ff-cb2a-4b16-b2c7-e35c6bf2de132025-12-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125472
ndc (product): 50242-143
ndc (product): 50242-138

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-138ActemratocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent
50242-143Actemra ACTPentocilizumabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84391SUPPL 2025-12-12
84386SUPPL 2025-12-11
83090SUPPL 2025-08-12
83074SUPPL 2025-08-11
83073SUPPL 2025-08-11
80561SUPPL 2024-12-13
80554SUPPL 2024-12-11
79714SUPPL 2024-09-24
79699SUPPL 2024-09-23
79678SUPPL 2024-09-23
79672SUPPL 2024-09-20
72995SUPPL2022-12-22
72989SUPPL2022-12-22
72988SUPPL2022-12-22
71537SUPPL2022-07-12
70337SUPPL2022-03-01
70336SUPPL2022-03-01
70309SUPPL2022-03-01
69084SUPPL2021-10-25
66684SUPPL2021-03-09
66681SUPPL2021-03-09
66569SUPPL2021-03-08
63357SUPPL2020-06-01
63344SUPPL2020-05-29
63343SUPPL2020-05-29
61000SUPPL2019-11-20
59037SUPPL2019-06-12
59036SUPPL2019-06-12
59028SUPPL2019-06-12
58332SUPPL2019-04-15
58301SUPPL2019-04-12
56991SUPPL2018-12-21
56963SUPPL2018-12-21
56518SUPPL2018-11-20
56515SUPPL2018-11-20
55484SUPPL2018-09-14
55464SUPPL2018-09-13
54269SUPPL2018-05-21
54262SUPPL2018-05-21
54199SUPPL2018-05-16
54173SUPPL2018-05-14
53483SUPPL2018-03-28
53097SUPPL2018-03-22
48513SUPPL2017-05-24
48509SUPPL2017-05-24
47823SUPPL2017-04-03
47802SUPPL2017-03-31
45390SUPPL2016-09-27
45401SUPPL2016-09-26
9764SUPPL2015-08-21
24372ORIG2014-07-17
22813ORIG2014-07-17
18918ORIG2013-10-25
9763ORIG2013-10-24