Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 100MG/10ML (10MG/ML) | 0 | RITUXAN | RITUXIMAB |
| 002 | SOLUTION;INTRAVENOUS | 500MG/50ML (10MG/ML) | 0 | RITUXAN | RITUXIMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 1997-11-26 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5209 | AP | 2006-02-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5211 | AP | 2006-02-28 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5230 | AP | 2006-09-29 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5231 | AP | 2006-09-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 5247 | AP | 2007-02-21 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5256 | AP | 2008-01-25 | STANDARD |
| LABELING; Labeling | SUPPL | 5259 | AP | 2007-08-22 | STANDARD |
| LABELING; Labeling | SUPPL | 5262 | AP | 2007-09-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5263 | AP | 2008-01-24 | STANDARD |
| LABELING; Labeling | SUPPL | 5285 | AP | 2008-09-08 | STANDARD |
| S; Supplement | SUPPL | 5291 | AP | 2008-09-08 | |
| EFFICACY; Efficacy | SUPPL | 5299 | AP | 2009-10-16 | STANDARD |
| LABELING; Labeling | SUPPL | 5310 | AP | 2009-09-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5311 | AP | 2010-02-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5312 | AP | 2010-02-18 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5332 | AP | 2011-01-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5334 | AP | 2010-10-06 | STANDARD |
| LABELING; Labeling | SUPPL | 5343 | AP | 2011-01-06 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5344 | AP | 2011-04-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 5362 | AP | 2012-02-17 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5367 | AP | 2012-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 5370 | AP | 2012-04-13 | STANDARD |
| LABELING; Labeling | SUPPL | 5373 | AP | 2012-07-13 | STANDARD |
| LABELING; Labeling | SUPPL | 5388 | AP | 2012-10-19 | |
| LABELING; Labeling | SUPPL | 5409 | AP | 2013-05-09 | STANDARD |
| LABELING; Labeling | SUPPL | 5414 | AP | 2013-09-24 | STANDARD |
| LABELING; Labeling | SUPPL | 5432 | AP | 2014-08-12 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5450 | AP | 2018-06-07 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 5451 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 5453 | AP | 2018-04-03 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5454 | AP | 2019-01-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5457 | AP | 2019-09-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 5458 | AP | 2020-03-13 | STANDARD |
| LABELING; Labeling | SUPPL | 5459 | AP | 2019-11-25 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5460 | AP | 2020-08-28 | STANDARD |
| LABELING; Labeling | SUPPL | 5461 | AP | 2020-01-23 | STANDARD |
| LABELING; Labeling | SUPPL | 5464 | AP | 2021-06-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5465 | AP | 2021-12-02 | PRIORITY |
| LABELING; Labeling | SUPPL | 5467 | AP | 2021-12-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Orphan | 5 |
| SUPPL | 5209 | Orphan | 5 |
| SUPPL | 5230 | Orphan | 5 |
| SUPPL | 5231 | Orphan | 5 |
| SUPPL | 5291 | Null | 0 |
| SUPPL | 5311 | Orphan | 5 |
| SUPPL | 5312 | Orphan | 5 |
| SUPPL | 5332 | Orphan | 5 |
| SUPPL | 5344 | Orphan | 5 |
| SUPPL | 5367 | Orphan | 5 |
| SUPPL | 5388 | Null | 0 |
| SUPPL | 5432 | Null | 15 |
| SUPPL | 5450 | Null | 7 |
| SUPPL | 5451 | Orphan | 5 |
| SUPPL | 5453 | Null | 7 |
| SUPPL | 5454 | Null | 15 |
| SUPPL | 5457 | Null | 7 |
| SUPPL | 5458 | Null | 15 |
| SUPPL | 5459 | Null | 8 |
| SUPPL | 5460 | Null | 15 |
| SUPPL | 5461 | Null | 7 |
| SUPPL | 5464 | Null | 15 |
| SUPPL | 5465 | Null | 6 |
| SUPPL | 5467 | Null | 15 |
CDER Filings
GENENTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 103705
[companyName] => GENENTECH
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/103705s5457lbl.pdf#page=46"]
[products] => [{"drugName":"RITUXAN","activeIngredients":"RITUXIMAB","strength":"100MG\/10ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RITUXAN","activeIngredients":"RITUXIMAB","strength":"500MG\/50ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"08\/28\/2020","submission":"SUPPL-5460","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103705s5460lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2020","submission":"SUPPL-5458","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103705Orig1s5458lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2020","submission":"SUPPL-5461","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103705s5461lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2019","submission":"SUPPL-5459","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103705s5459lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2019","submission":"SUPPL-5457","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103705s5457lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2019","submission":"SUPPL-5454","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103705s5454lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-5451","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103705s5451lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2018","submission":"SUPPL-5450","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103705s5450lbl.pdf\"}]","notes":""},{"actionDate":"04\/03\/2018","submission":"SUPPL-5453","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/103705s5453lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2014","submission":"SUPPL-5432","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103705s5432lbl.pdf\"}]","notes":""},{"actionDate":"09\/24\/2013","submission":"SUPPL-5414","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103705s5414lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2013","submission":"SUPPL-5409","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103705s5409lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2012","submission":"SUPPL-5388","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103705s5367s5388lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2012","submission":"SUPPL-5367","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103705s5367s5388lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2012","submission":"SUPPL-5373","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103705s5373lbl.pdf\"}]","notes":""},{"actionDate":"04\/13\/2012","submission":"SUPPL-5370","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103705s5370lbl.pdf\"}]","notes":""},{"actionDate":"02\/17\/2012","submission":"SUPPL-5362","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103705s5362lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2011","submission":"SUPPL-5344","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103705s5344lbl.pdf\"}]","notes":""},{"actionDate":"01\/28\/2011","submission":"SUPPL-5332","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103705s5332lbl.pdf\"}]","notes":""},{"actionDate":"01\/06\/2011","submission":"SUPPL-5343","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103705s5343lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2010","submission":"SUPPL-5312","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103705s5312lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2010","submission":"SUPPL-5311","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/103705s5311lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2009","submission":"SUPPL-5299","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/103705s5299lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2008","submission":"SUPPL-5256","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103705s5256lbl.pdf\"}]","notes":""},{"actionDate":"01\/24\/2008","submission":"SUPPL-5263","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103705s5263lbl.pdf\"}]","notes":""},{"actionDate":"09\/28\/2007","submission":"SUPPL-5262","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103705s5262lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2007","submission":"SUPPL-5259","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103705s5259lbl.pdf\"}]","notes":""},{"actionDate":"02\/21\/2007","submission":"SUPPL-5247","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103705s5247Lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2006","submission":"SUPPL-5231","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103705s5230-s5231lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2006","submission":"SUPPL-5230","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103705s5230-s5231lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2006","submission":"SUPPL-5211","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103705s5211_lbl.pdf\"}]","notes":""},{"actionDate":"02\/10\/2006","submission":"SUPPL-5209","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/103705s5209lbl.pdf\"}]","notes":""},{"actionDate":"11\/26\/1997","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/ritugen112697-lab.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"11\/26\/1997","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1997\\\/ritugen112697-lab.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1997\\\/ritugen112697L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170210011738\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm093345.htm\"}]","notes":">"}]
[supplements] => [{"actionDate":"01\/23\/2020","submission":"SUPPL-5461","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103705s5461lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103705Orig1s5461ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2020","submission":"SUPPL-5460","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103705s5460lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103705Orig1s5460ltr.pdf\"}]","notes":">"},{"actionDate":"11\/25\/2019","submission":"SUPPL-5459","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label 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[actionDate] => 2020-08-28
)
)