Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 103705
Company: GENENTECH
Company: GENENTECH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RITUXAN | RITUXIMAB | 100MG/10ML (10MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | No | No |
| RITUXAN | RITUXIMAB | 500MG/50ML (10MG/ML) | SOLUTION;INTRAVENOUS | 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://web.archive.org/web/20170210011738/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 |
|---|---|---|---|---|---|
| 12/17/2021 | SUPPL-5467 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5467lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103705Orig1s5467ltr.pdf | |
| 12/02/2021 | SUPPL-5465 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103705Orig1s5465ltr.pdf | |
| 06/30/2021 | SUPPL-5464 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5464lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103705Orig1s5464ltr.pdf | |
| 01/23/2020 | SUPPL-5461 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103705s5461lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103705Orig1s5461ltr.pdf | |
| 08/28/2020 | SUPPL-5460 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103705s5460lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103705Orig1s5460ltr.pdf | |
| 11/25/2019 | SUPPL-5459 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5459lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103705Orig1s5459ltr.pdf | |
| 03/13/2020 | SUPPL-5458 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103705Orig1s5458lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103705Orig1s5458ltr.pdf | |
| 09/27/2019 | SUPPL-5457 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103705Orig1s5457ltr.pdf | |
| 01/25/2019 | SUPPL-5454 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5454lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103705Orig1s5454ltr.pdf | |
| 04/03/2018 | SUPPL-5453 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103705Orig1s5453ltr.pdf | |
| 10/18/2018 | SUPPL-5451 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5451lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103705Orig1s5451ltr.pdf | |
| 06/07/2018 | SUPPL-5450 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5450lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103705Orig1s5450ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 12/17/2021 | SUPPL-5467 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5467lbl.pdf | |
| 12/02/2021 | SUPPL-5465 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5465lbl.pdf | |
| 06/30/2021 | SUPPL-5464 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103705s5464lbl.pdf | |
| 08/28/2020 | SUPPL-5460 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103705s5460lbl.pdf | |
| 03/13/2020 | SUPPL-5458 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103705Orig1s5458lbl.pdf | |
| 01/23/2020 | SUPPL-5461 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103705s5461lbl.pdf | |
| 11/25/2019 | SUPPL-5459 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5459lbl.pdf | |
| 09/27/2019 | SUPPL-5457 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5457lbl.pdf | |
| 01/25/2019 | SUPPL-5454 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103705s5454lbl.pdf | |
| 10/18/2018 | SUPPL-5451 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5451lbl.pdf | |
| 06/07/2018 | SUPPL-5450 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5450lbl.pdf | |
| 04/03/2018 | SUPPL-5453 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103705s5453lbl.pdf | |
| 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 |