FDA.reportPublic FDA data

Application 103976

Type
BLA
Sponsor
GENENTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001XOLAIROMALIZUMABVIAL150MG/VIALNoNo
002XOLAIROMALIZUMABSYRINGE75MG/0.5MLNoNo
003XOLAIROMALIZUMABSYRINGE150MG/MLNoNo
004XOLAIROMALIZUMABSYRINGE300MG/2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-040XOLAIRomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-214Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent
50242-215Xolair PFSomalizumabGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77574SUPPL 2024-02-20
77512SUPPL 2024-02-16
77511SUPPL 2024-02-16
76584SUPPL 2023-11-16
74164SUPPL 2023-05-03
73806SUPPL 2023-03-20
70561SUPPL2022-03-18
70560SUPPL2022-03-18
70559SUPPL2022-03-18
67031SUPPL2021-04-13
67022SUPPL2021-04-12
67021SUPPL2021-04-12
65849SUPPL2021-01-07
65848SUPPL2021-01-07
65468SUPPL2020-12-02
65445SUPPL2020-12-01
65444SUPPL2020-12-01
58530SUPPL2019-05-02
58529SUPPL2019-05-02
58524SUPPL2019-05-02
55798SUPPL2018-10-03
55768SUPPL2018-10-01
18723SUPPL2016-07-08
9531SUPPL2016-07-07
39773SUPPL2015-12-08
9530SUPPL2015-12-08
9529SUPPL2014-10-01
39772SUPPL2014-09-30
31759SUPPL2014-03-25
18722SUPPL2014-03-25
31758SUPPL2012-01-05
31757SUPPL2011-01-10
31756SUPPL2010-02-05
18721SUPPL2007-07-02
31755SUPPL2006-04-14
18720SUPPL2006-04-14
44424ORIG2004-03-30
18719ORIG2004-03-30
9528ORIG2004-03-30
68909ORIG1900-01-01
68908ORIG1900-01-01
68907ORIG1900-01-01
68906ORIG1900-01-01
68905ORIG1900-01-01
68904ORIG1900-01-01
68903ORIG1900-01-01
64995ORIG1900-01-01
63188ORIG1900-01-01
63187ORIG1900-01-01
63186ORIG1900-01-01
51624SUPPL1900-01-01
51623SUPPL1900-01-01
51622SUPPL1900-01-01
51621ORIG1900-01-01
51620ORIG1900-01-01
51619ORIG1900-01-01