Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 30MG/1ML | 0 | OCREVUS | OCRELIZUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2017-03-28 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 12 | AP | 2018-11-12 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2019-07-16 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2020-01-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 22 | AP | 2020-12-14 | STANDARD |
| LABELING; Labeling | SUPPL | 23 | AP | 2020-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2020-05-15 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2022-08-03 | STANDARD |
| LABELING; Labeling | SUPPL | 30 | AP | 2022-08-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 12 | Null | 6 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 20 | Null | 7 |
| SUPPL | 22 | Null | 15 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 30 | Null | 46 |
CDER Filings
GENENTECH INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761053
[companyName] => GENENTECH INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761053s024lbl.pdf#page=18"]
[products] => [{"drugName":"OCREVUS","activeIngredients":"OCRELIZUMAB","strength":"30MG\/1ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"05\/15\/2020","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761053s024lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2020","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761053s020lbl.pdf\"}]","notes":""},{"actionDate":"07\/16\/2019","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761053s018lbl.pdf\"}]","notes":""},{"actionDate":"11\/12\/2018","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761053s012lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761053lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"03\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761053lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761053Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761053Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/15\/2020","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761053s024lbl.pdf\"}]","notes":">"},{"actionDate":"01\/10\/2020","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761053s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761053Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"07\/16\/2019","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761053s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761053Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"11\/12\/2018","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761053s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761053Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2017","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-05-15
)
)