FDA.reportPublic FDA data

Application 125526

Type
BLA
Sponsor
GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUCALAMEPOLIZUMABINJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0881NucalamepolizumabGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82416SUPPL 2025-06-02
82311SUPPL 2025-05-27
73786SUPPL 2023-03-17
73774SUPPL 2023-03-16
69974SUPPL2022-01-26
69957SUPPL2022-01-25
68267SUPPL2021-08-02
68250SUPPL2021-08-02
64735SUPPL2020-09-29
64696SUPPL2020-09-28
60000SUPPL2019-09-13
59992SUPPL2019-09-13
58992SUPPL2019-06-07
58986SUPPL2019-06-07
51329ORIG2018-01-22
50750SUPPL2017-12-18
50677SUPPL2017-12-13
47264SUPPL2017-02-17
24379ORIG2015-12-11
22821ORIG2015-12-11
39988ORIG2015-11-05
9779ORIG2015-11-05
64657ORIG1900-01-01
63140SUPPL1900-01-01
51331ORIG1900-01-01
51330ORIG1900-01-01
51328ORIG1900-01-01