Application 761053

Type
BLA
Sponsor
GENENTECH INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCREVUSOCRELIZUMABINJECTABLE;INJECTION30MG/1MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent
50242-150OCREVUSocrelizumabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85957SUPPL 2026-05-19
85861SUPPL 2026-05-18
85873SUPPL 2026-05-11
83150SUPPL 2025-08-20
83137SUPPL 2025-08-19
78882SUPPL 2024-06-24
78872SUPPL 2024-06-24
77281SUPPL 2024-01-23
77255SUPPL 2024-01-22
75238SUPPL 2023-08-22
75207SUPPL 2023-08-22
71737SUPPL2022-08-05
71736SUPPL2022-08-05
71735SUPPL2022-08-05
71719SUPPL2022-08-04
71718SUPPL2022-08-04
65597SUPPL2020-12-15
65588SUPPL2020-12-14
65196SUPPL2020-11-12
65180SUPPL2020-11-10
65176SUPPL2020-11-10
63289SUPPL2020-05-26
63148SUPPL2020-05-19
61570SUPPL2020-01-14
61569SUPPL2020-01-14
61557SUPPL2020-01-14
59372SUPPL2019-07-18
59359SUPPL2019-07-17
56430SUPPL2018-11-23
56480SUPPL2018-11-15
48328ORIG2017-05-09
47772ORIG2017-03-30
47771ORIG2017-03-30
47770ORIG2017-03-30