Tools / Drug approvals and letters / Drugs Rituxan BLA 103705, held by Genentech . Rituximab
As of Nov 13, 2026, BLA 103705 (Rituxan), held by Genentech, was first approved by FDA on Nov 26, 1997, with 39 approved supplements and 0 published complete response letters.
First approved : Nov 26, 1997 Review : Priority Supplements approved : 39 Complete response letters : 0
Approvals and New Uses The original application and every efficacy supplement, newest first; all 40 submissions below Date Submission Status Documents Dec 2, 2021 Supplement 5465Efficacy (new indication or use) · Priority review Approved Letter Label Medication Guide Aug 28, 2020 Supplement 5460Efficacy (new indication or use) · Standard review Approved Label Letter Sep 27, 2019 Supplement 5457Efficacy (new indication or use) · Priority review Approved Letter Label Medication Guide Jan 25, 2019 Supplement 5454Efficacy (new indication or use) · Standard review Approved Letter Label Oct 18, 2018 Supplement 5451Efficacy (new indication or use) · Standard review Approved Letter Label Jun 7, 2018 Supplement 5450Efficacy (new indication or use) · Priority review Approved Letter Label Oct 19, 2012 Supplement 5367Efficacy (new indication or use) · Standard review Approved Letter Label Apr 19, 2011 Supplement 5344Efficacy (new indication or use) · Priority review Approved Review Letter Label Jan 28, 2011 Supplement 5332Efficacy (new indication or use) · Standard review Approved Letter Label Feb 18, 2010 Supplement 5312Efficacy (new indication or use) · Priority review Approved Letter Label Feb 18, 2010 Supplement 5311Efficacy (new indication or use) · Priority review Approved Letter Label Oct 16, 2009 Supplement 5299Efficacy (new indication or use) · Standard review Approved Letter Label Jan 25, 2008 Supplement 5256Efficacy (new indication or use) · Standard review Approved Letter Label Sep 29, 2006 Supplement 5231Efficacy (new indication or use) · Priority review Approved Label Sep 29, 2006 Supplement 5230Efficacy (new indication or use) · Priority review Approved Letter Label Feb 28, 2006 Supplement 5211Efficacy (new indication or use) · Priority review Approved Letter Label Feb 10, 2006 Supplement 5209Efficacy (new indication or use) · Priority review Approved Label Nov 26, 1997 Original applicationNew molecular entity · Priority review Approved Letter Label
Products 2 strengths and forms Product Active ingredient Marketing Rituxan100MG/10ML (10MG/ML) · solution;intravenous Rituximab Rx Rituxan500MG/50ML (10MG/ML) · solution;intravenous Rituximab Rx
All 40 submissions, including labeling and manufacturing supplements Date Submission Status Documents Dec 17, 2021 Supplement 5467Labeling · Standard review Approved Letter Label Dec 2, 2021 Supplement 5465Efficacy (new indication or use) · Priority review Approved Letter Label Medication Guide Jun 30, 2021 Supplement 5464Labeling · Standard review Approved Label Letter Aug 28, 2020 Supplement 5460Efficacy (new indication or use) · Standard review Approved Label Letter Mar 13, 2020 Supplement 5458Labeling · Standard review Approved Letter Label Jan 23, 2020 Supplement 5461Labeling · Standard review Approved Letter Label Nov 25, 2019 Supplement 5459Labeling · Standard review Approved Label Letter Sep 27, 2019 Supplement 5457Efficacy (new indication or use) · Priority review Approved Letter Label Medication Guide Jan 25, 2019 Supplement 5454Efficacy (new indication or use) · Standard review Approved Letter Label Oct 18, 2018 Supplement 5451Efficacy (new indication or use) · Standard review Approved Letter Label Jun 7, 2018 Supplement 5450Efficacy (new indication or use) · Priority review Approved Letter Label Apr 3, 2018 Supplement 5453Labeling · Standard review Approved Letter Label Aug 12, 2014 Supplement 5432Labeling · Standard review Approved Letter Label Sep 24, 2013 Supplement 5414Labeling · Standard review Approved Label Letter May 9, 2013 Supplement 5409Labeling · Standard review Approved Label Letter Oct 19, 2012 Supplement 5388Labeling Approved Letter Label Oct 19, 2012 Supplement 5367Efficacy (new indication or use) · Standard review Approved Letter Label Jul 13, 2012 Supplement 5373Labeling · Standard review Approved Label Letter Apr 13, 2012 Supplement 5370Labeling · Standard review Approved Label Letter Feb 17, 2012 Supplement 5362Labeling · Standard review Approved Letter Label Apr 19, 2011 Supplement 5344Efficacy (new indication or use) · Priority review Approved Review Letter Label Jan 28, 2011 Supplement 5332Efficacy (new indication or use) · Standard review Approved Letter Label Jan 6, 2011 Supplement 5343Labeling · Standard review Approved Letter Label Oct 6, 2010 Supplement 5334Labeling · Standard review Approved None posted Feb 18, 2010 Supplement 5312Efficacy (new indication or use) · Priority review Approved Letter Label Feb 18, 2010 Supplement 5311Efficacy (new indication or use) · Priority review Approved Letter Label Oct 16, 2009 Supplement 5299Efficacy (new indication or use) · Standard review Approved Letter Label Sep 22, 2009 Supplement 5310Labeling · Standard review Approved None posted Sep 8, 2008 Supplement 5291 Approved Letter Sep 8, 2008 Supplement 5285Labeling · Standard review Approved Letter Jan 25, 2008 Supplement 5256Efficacy (new indication or use) · Standard review Approved Letter Label Jan 24, 2008 Supplement 5263Labeling · Standard review Approved Label Sep 28, 2007 Supplement 5262Labeling · Standard review Approved Label Letter Aug 22, 2007 Supplement 5259Labeling · Standard review Approved Letter Label Feb 21, 2007 Supplement 5247Labeling · Standard review Approved Label Letter Sep 29, 2006 Supplement 5231Efficacy (new indication or use) · Priority review Approved Label Sep 29, 2006 Supplement 5230Efficacy (new indication or use) · Priority review Approved Letter Label Feb 28, 2006 Supplement 5211Efficacy (new indication or use) · Priority review Approved Letter Label Feb 10, 2006 Supplement 5209Efficacy (new indication or use) · Priority review Approved Label Nov 26, 1997 Original applicationNew molecular entity · Priority review Approved Letter Label
Identifiers
Application BLA 103705 Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
