FDA.reportPublic FDA data

Application 761041

Type
BLA
Sponsor
GENENTECH INC

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
ndc (product): 50242-918

NDC Listings For This Application#

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

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
46566ORIG2016-12-27
46565ORIG2016-12-27
45959ORIG2016-11-28
45632ORIG2016-10-20
45626ORIG2016-10-18