Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125326
Company: GLAXO GRP LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARZERRA OFATUMUMAB 100MG/5ML 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
10/26/2009 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125326s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125326s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/30/2016 SUPPL-63 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s063ltr.pdf
01/19/2016 SUPPL-62 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125326Orig1s062ltr.pdf
04/17/2014 SUPPL-60 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125326s060lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125326Orig1s060ltr.pdf
09/24/2013 SUPPL-59 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125326s059lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125326Orig1s059ltr.pdf
09/20/2011 SUPPL-32 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125326s0032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125326s0032ltr.pdf
09/23/2010 SUPPL-12 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/30/2016 SUPPL-63 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf
01/19/2016 SUPPL-62 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s062lbl.pdf
04/17/2014 SUPPL-60 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125326s060lbl.pdf
09/24/2013 SUPPL-59 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125326s059lbl.pdf
09/20/2011 SUPPL-32 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125326s0032lbl.pdf
10/26/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125326lbl.pdf

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