FDA.reportPublic FDA data

Application 761122

Type
BLA
Sponsor
GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUCALAMEPOLIZUMABINJECTABLE;SUBCUTANEOUS100MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0892NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0904NucalamepolizumabGlaxoSmithKline LLCBLACurrent
0173-0904NucalamepolizumabGlaxoSmithKline LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83128SUPPL 2025-08-19
83062SUPPL 2025-08-07
73785SUPPL 2023-03-17
73775SUPPL 2023-03-16
69973SUPPL2022-01-26
69958SUPPL2022-01-25
68266SUPPL2021-08-02
68249SUPPL2021-08-02
64739SUPPL2020-09-29
64673SUPPL2020-09-25
60002SUPPL2019-09-13
60001SUPPL2019-09-13
59994SUPPL2019-09-13
59993SUPPL2019-09-13
59839ORIG2019-08-26
58995ORIG2019-06-07
58987ORIG2019-06-07
66960ORIG1900-01-01
63141ORIG1900-01-01