FDA.reportPublic FDA data

Application 761060

Type
BLA
Sponsor
WYETH PHARMS INC

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761060Mylotarggemtuzumab ozogamicin351(a)Rx2026-08-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYLOTARGGEMTUZUMAB OZOGAMICINVIAL;SINGLE-DOSE4.5MGNoNo

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
MylotargGEMTUZUMAB OZOGAMICINWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.32fd2bb2-1cfa-4250-feb8-d7956c794e052025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761060
ndc (product): 0008-4510

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.BLACurrent
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent
0008-4510Mylotarggemtuzumab ozogamicinWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63586SUPPL2020-06-17
63575SUPPL2020-06-16
61990SUPPL2020-02-28
61989SUPPL2020-02-28
54476ORIG2018-06-08
54475ORIG2018-06-08
53663SUPPL2018-04-12
53657SUPPL2018-04-12
49679ORIG2017-09-06
49678ORIG2017-09-06
49653ORIG2017-09-01