FDA.reportPublic FDA data

Application 761060

Type
BLA
Sponsor
WYETH PHARMS INC

Application Products#

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

NDC Listings For This Application#

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