FDA.reportPublic FDA data

Application 125019

Type
BLA
Sponsor
SPECTRUM PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEVALINIBRITUMOMAB TIUXETANINJECTABLE; INJECTION3.2MG/2MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68152-103Zevalinibritumomab tiuxetanSpectrum Pharmaceuticals, Inc.BLACurrent
72893-007Zevalinibritumomab tiuxetanAcrotech Biopharma LLCBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56843SUPPL2018-12-20
56714SUPPL2018-12-12
39784SUPPL2013-09-09
39783SUPPL2013-09-09
31769SUPPL2013-09-05
9541SUPPL2013-09-05
31768SUPPL2011-12-02
18733SUPPL2011-11-30
39782SUPPL2009-09-18
9540SUPPL2009-09-10
9539SUPPL2008-03-28
18732SUPPL2008-03-27
39781SUPPL2007-11-13
31767SUPPL2007-11-08
22770ORIG2005-12-08
39780SUPPL2005-09-15
31766SUPPL2005-09-15
39779SUPPL2005-08-08
31765SUPPL2005-08-08
39778SUPPL2005-01-26
39777SUPPL2005-01-26
31764SUPPL2005-01-26
9538SUPPL2005-01-26
31763ORIG2004-03-30
18731ORIG2004-03-30