Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 103705
Company: GENENTECH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RITUXAN RITUXIMAB 10MG/ML VIAL 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
11/26/1997 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ritugen112697-lab.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1997/ritugen112697L.htm https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/ucm093345.htm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/12/2014 SUPPL-5432 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103705s5432lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103705Orig1s5432ltr.pdf
09/24/2013 SUPPL-5414 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5414lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5414ltr.pdf
05/09/2013 SUPPL-5409 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5409lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/103705Orig1s5409ltr.pdf
10/19/2012 SUPPL-5388 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388ltr.pdf
07/13/2012 SUPPL-5373 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5373lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5373ltr.pdf
04/13/2012 SUPPL-5370 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5370lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5370ltr.pdf
10/19/2012 SUPPL-5367 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705Orig1s5367,s5388ltr.pdf
02/17/2012 SUPPL-5362 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5362lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/103705s5362ltr.pdf
04/19/2011 SUPPL-5344 Supplement Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5344lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5344ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2011/103705Orig1s5344.pdf
01/06/2011 SUPPL-5343 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5343lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5343ltr.pdf
10/06/2010 SUPPL-5334 Supplement

Label is not available on this site.

01/28/2011 SUPPL-5332 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5332lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103705s5332ltr.pdf
02/18/2010 SUPPL-5312 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5312lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5312ltr.pdf
02/18/2010 SUPPL-5311 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103705s5311ltr.pdf
09/22/2009 SUPPL-5310 Supplement

Label is not available on this site.

10/16/2009 SUPPL-5299 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103705s5299lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/103705s5299ltr.pdf
09/08/2008 SUPPL-5291 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5291ltr.pdf
09/08/2008 SUPPL-5285 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5285ltr.pdf
01/24/2008 SUPPL-5263 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5263lbl.pdf
09/28/2007 SUPPL-5262 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5262lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5262ltr.pdf
08/22/2007 SUPPL-5259 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5259lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5259ltr.pdf
01/25/2008 SUPPL-5256 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5256lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/103705s5256ltr.pdf
02/21/2007 SUPPL-5247 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5247Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103705s5247Ltr.pdf
09/29/2006 SUPPL-5231 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf
09/29/2006 SUPPL-5230 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5230LTR.pdf
02/28/2006 SUPPL-5211 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5211_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103705s5211_ltr.pdf
02/10/2006 SUPPL-5209 Supplement Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5209lbl.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/12/2014 SUPPL-5432 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103705s5432lbl.pdf
09/24/2013 SUPPL-5414 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5414lbl.pdf
05/09/2013 SUPPL-5409 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/103705s5409lbl.pdf
10/19/2012 SUPPL-5388 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf
10/19/2012 SUPPL-5367 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf
07/13/2012 SUPPL-5373 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5373lbl.pdf
04/13/2012 SUPPL-5370 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5370lbl.pdf
02/17/2012 SUPPL-5362 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5362lbl.pdf
04/19/2011 SUPPL-5344 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5344lbl.pdf
01/28/2011 SUPPL-5332 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5332lbl.pdf
01/06/2011 SUPPL-5343 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/103705s5343lbl.pdf
02/18/2010 SUPPL-5312 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5312lbl.pdf
02/18/2010 SUPPL-5311 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/103705s5311lbl.pdf
10/16/2009 SUPPL-5299 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103705s5299lbl.pdf
01/25/2008 SUPPL-5256 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5256lbl.pdf
01/24/2008 SUPPL-5263 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103705s5263lbl.pdf
09/28/2007 SUPPL-5262 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5262lbl.pdf
08/22/2007 SUPPL-5259 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5259lbl.pdf
02/21/2007 SUPPL-5247 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103705s5247Lbl.pdf
09/29/2006 SUPPL-5231 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf
09/29/2006 SUPPL-5230 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5230-s5231lbl.pdf
02/28/2006 SUPPL-5211 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5211_lbl.pdf
02/10/2006 SUPPL-5209 Efficacy Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103705s5209lbl.pdf
11/26/1997 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1997/ritugen112697-lab.pdf

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