Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125019
Company: SPECTRUM PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEVALIN IBRITUMOMAB TIUXETAN 3.2MG/2ML INJECTABLE; INJECTION Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/19/2002 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/ibriide021902L.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/125019_0000_ZevalinTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/11/2018 SUPPL-227 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125019s227lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125019Orig1s227ltr.pdf
08/30/2013 SUPPL-213 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf
08/30/2013 SUPPL-210 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125019Orig1s210,s213ltr.pdf
11/18/2011 SUPPL-194 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125019s0194ltr.pdf
12/16/2010 SUPPL-185 Supplement

Label is not available on this site.

09/03/2009 SUPPL-156 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125019s0156ltr.pdf
03/25/2008 SUPPL-135 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125019s0135ltr.pdf
11/02/2007 SUPPL-132 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/125019s132ltr.pdf
01/04/2007 SUPPL-117 Supplement

Label is not available on this site.

09/13/2005 SUPPL-92 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0092ltr.pdf
07/27/2005 SUPPL-88 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/125019_0088ltr.pdf
10/29/2004 SUPPL-70 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0070ltr.pdf
10/22/2004 SUPPL-58 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125019_0058ltr.pdf
01/30/2003 SUPPL-8 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/11/2018 SUPPL-227 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125019s227lbl.pdf
08/30/2013 SUPPL-213 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf
08/30/2013 SUPPL-210 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125019s210s213lbl.pdf
11/18/2011 SUPPL-194 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125019s0194lbl.pdf
09/03/2009 SUPPL-156 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125019s0156.pdf
03/25/2008 SUPPL-135 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125019s135lbl.pdf
11/02/2007 SUPPL-132 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/125019s132lbl.pdf
09/13/2005 SUPPL-92 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0092lbl.pdf
07/27/2005 SUPPL-88 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/125019_0088lbl.pdf
10/29/2004 SUPPL-70 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0070lbl.pdf
10/22/2004 SUPPL-58 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125019_0058lbl.pdf
02/19/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/ibriide021902LB.pdf

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