FDA.reportPublic FDA data

Application 761040

Type
BLA
Sponsor
WYETH PHARMS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761040Besponsainotuzumab ozogamicin351(a)Rx2026-07-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BESPONSAINOTUZUMAB OZOGAMICINPOWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER0.9/MG/VIALYesNo

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
BesponsaINOTUZUMAB OZOGAMICINWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.cc7014b1-c775-411d-b374-8113248b40772026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761040
ndc (product): 0008-0100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-0100Besponsainotuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent
0008-0100Besponsainotuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77783SUPPL 2024-03-12
77735SUPPL 2024-03-06
49866ORIG2017-09-27
49460ORIG2017-08-18
49442ORIG2017-08-17