FDA.reportPublic FDA data

Application 761122

Type
BLA
Sponsor
GLAXOSMITHKLINE

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761122Nucalamepolizumab351(a)Rx2026-08-01

Application Products#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NucalaMEPOLIZUMABGlaxoSmithKline LLCfefb887c-e4ac-431e-8893-e9d1a5a63fea2025-08-06Warnings, Adverse reactionsExact identifier
application number: BLA761122
ndc (product): 0173-0892
ndc (product): 0173-0904

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

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