FDA.reportPublic FDA data

Application 761040

Type
BLA
Sponsor
WYETH PHARMS INC

Application Products#

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

NDC Listings For This Application#

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