FDA.report

Application 103948

Type
BLA
Sponsor
GENZYME

Related Records

Application Products

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

NDC Listings For This Application

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

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