FDA.reportPublic FDA data

Application 761083

Type
BLA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEMLIBRAEMICIZUMABINJECTABLE;INJECTION30MG/MLYesNo
002HEMLIBRAEMICIZUMABINJECTABLE;INJECTION60MG/0.4MLYesNo
003HEMLIBRAEMICIZUMABINJECTABLE;INJECTION105MG/0.7MLYesNo
004HEMLIBRAEMICIZUMABINJECTABLE;INJECTION150MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-920HemlibraemicizumabGenentech, Inc.BLACurrent
50242-920HemlibraemicizumabGenentech, Inc.BLACurrent
50242-920HemlibraemicizumabGenentech, Inc.BLACurrent
50242-920HemlibraemicizumabGenentech, Inc.BLACurrent
50242-920HemlibraemicizumabGenentech, Inc.BLACurrent
50242-920HemlibraemicizumabGenentech, Inc.BLACurrent
50242-920HemlibraemicizumabGenentech, Inc.BLACurrent
50242-921HemlibraemicizumabGenentech, Inc.BLACurrent
50242-921HemlibraemicizumabGenentech, Inc.BLACurrent
50242-921HemlibraemicizumabGenentech, Inc.BLACurrent
50242-921HemlibraemicizumabGenentech, Inc.BLACurrent
50242-921HemlibraemicizumabGenentech, Inc.BLACurrent
50242-921HemlibraemicizumabGenentech, Inc.BLACurrent
50242-921HemlibraemicizumabGenentech, Inc.BLACurrent
50242-922HemlibraemicizumabGenentech, Inc.BLACurrent
50242-922HemlibraemicizumabGenentech, Inc.BLACurrent
50242-922HemlibraemicizumabGenentech, Inc.BLACurrent
50242-922HemlibraemicizumabGenentech, Inc.BLACurrent
50242-922HemlibraemicizumabGenentech, Inc.BLACurrent
50242-922HemlibraemicizumabGenentech, Inc.BLACurrent
50242-922HemlibraemicizumabGenentech, Inc.BLACurrent
50242-923HemlibraemicizumabGenentech, Inc.BLACurrent
50242-923HemlibraemicizumabGenentech, Inc.BLACurrent
50242-923HemlibraemicizumabGenentech, Inc.BLACurrent
50242-923HemlibraemicizumabGenentech, Inc.BLACurrent
50242-923HemlibraemicizumabGenentech, Inc.BLACurrent
50242-923HemlibraemicizumabGenentech, Inc.BLACurrent
50242-923HemlibraemicizumabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82782SUPPL 2025-07-11
82781SUPPL 2025-07-11
82763SUPPL 2025-07-09
77391SUPPL 2024-02-02
77382SUPPL 2024-02-01
71864SUPPL2022-08-23
71863SUPPL2022-08-23
71232SUPPL2022-06-07
69709SUPPL2021-12-21
69623SUPPL2021-12-17
69622SUPPL2021-12-17
68582SUPPL2021-09-10
68581SUPPL2021-09-10
68547SUPPL2021-09-07
55885SUPPL2018-10-11
55884SUPPL2018-10-11
55810SUPPL2018-10-04
55809SUPPL2018-10-04
55808SUPPL2018-10-04
55807SUPPL2018-10-04
50944ORIG2017-12-29
50444ORIG2017-11-17
50432ORIG2017-11-16