Application 125156

Type
BLA
Sponsor
GENENTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUCENTISRANIBIZUMABINJECTABLE; INJECTION10MG/MLNoNo
002LUCENTISRANIBIZUMABInjectable; Injection6MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-080LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent
50242-082LUCENTISRANIBIZUMABGenentech, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77582SUPPL 2024-02-20
77549SUPPL 2024-02-16
67700SUPPL2021-06-04
58922SUPPL2019-06-03
57210SUPPL2019-01-14
57209SUPPL2019-01-14
57208SUPPL2019-01-14
54462SUPPL2018-06-05
53493SUPPL2018-03-28
48056SUPPL2017-04-18
48052SUPPL2017-04-18
46838SUPPL2017-01-13
46725SUPPL2017-01-06
45980SUPPL2016-12-01
45958SUPPL2016-11-25
45634SUPPL2016-10-17
45614SUPPL2016-10-17
9631SUPPL2015-02-10
18811SUPPL2015-02-09
9630SUPPL2014-11-28
18810SUPPL2014-11-26
39863SUPPL2014-03-04
31853SUPPL2014-03-04
43306SUPPL2014-01-17
9629SUPPL2013-03-12
31852SUPPL2013-02-08
18809SUPPL2013-02-08
18808SUPPL2012-08-15
18807SUPPL2012-08-15
31851SUPPL2012-08-13
31850SUPPL2012-08-13
18806SUPPL2010-07-06
31849SUPPL2010-07-02
22790ORIG2006-09-26
18805ORIG2006-07-13
9628ORIG2006-07-13