FDA.reportPublic FDA data

Application 103948

Type
BLA
Sponsor
GENZYME

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103948Campathalemtuzumab351(a)Disc2026-06-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CAMPATHALEMTUZUMABVIAL; INTRAVENOUS10MG/MLNoNo
002CAMPATHALEMTUZUMABVIAL; INTRAVENOUS30MG/MLNoNo
003LEMTRADAALEMTUZUMABINJECTABLE;INJECTION12MG/1.2ML (10MG/ML)NoNo

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CampathALEMTUZUMABGenzyme Corporation4f5f7255-7abc-4328-bd1a-ceaf139ef3e02025-11-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103948
ndc (product): 58468-0357
LEMTRADAALEMTUZUMABGenzyme Corporation6236b0bc-82e9-4447-9a78-f57d947702692025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA103948
ndc (product): 58468-0200

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0200LEMTRADAALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent
58468-0357CampathALEMTUZUMABGenzyme CorporationBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78542SUPPL 2024-05-22
78541SUPPL 2024-05-22
78522SUPPL 2024-05-21
77713SUPPL 2024-03-05
77463SUPPL 2024-02-12
77446SUPPL 2024-02-09
74105SUPPL 2023-04-27
74095SUPPL 2023-04-27
72171SUPPL2022-09-28
72166SUPPL2022-09-27
71194SUPPL2022-06-01
71193SUPPL2022-06-01
71162SUPPL2022-05-27
70451SUPPL2022-03-09
69889SUPPL2022-01-18
69882SUPPL2022-01-14
68424SUPPL2021-08-19
68423SUPPL2021-08-19
68410SUPPL2021-08-19
67383SUPPL2021-05-04
67382SUPPL2021-05-04
67257SUPPL2021-04-29
66784SUPPL2021-03-16
65027SUPPL2020-10-26
64990SUPPL2020-10-23
64746SUPPL2020-09-29
64745SUPPL2020-09-29
64744SUPPL2020-09-29
64733SUPPL2020-09-29
64732SUPPL2020-09-29
63768SUPPL2020-07-01
63756SUPPL2020-06-30
63341SUPPL2020-05-29
63340SUPPL2020-05-29
63333SUPPL2020-05-29
61115SUPPL2019-11-29
61074SUPPL2019-11-27
60735SUPPL2019-10-30
60734SUPPL2019-10-30
60733SUPPL2019-10-30
60732SUPPL2019-10-30
60716SUPPL2019-10-30
60715SUPPL2019-10-30
59559SUPPL2019-08-02
59536SUPPL2019-08-01
58427SUPPL2019-04-26
57678SUPPL2019-02-15
57303SUPPL2019-01-22
57238SUPPL2019-01-17
57237SUPPL2019-01-17
56822SUPPL2018-12-20
56805SUPPL2018-12-19
56804SUPPL2018-12-19
56619SUPPL2018-12-03
56618SUPPL2018-12-03
56606SUPPL2018-11-30
54913SUPPL2018-07-18
53951SUPPL2017-12-15
53952SUPPL2017-12-14
53977SUPPL2015-09-22
53950ORIG2015-07-02
53949ORIG2005-11-30
53948ORIG2005-09-13
53976SUPPL2004-05-19
53947ORIG2004-03-12
53946ORIG2004-03-12