Documents
Application Sponsors
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 1000MG/40ML | 0 | GAZYVA | OBINUTUZUMAB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2013-11-01 | PRIORITY |
| LABELING; Labeling | SUPPL | 8 | AP | 2014-06-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2014-12-24 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2015-09-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2016-02-26 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2017-11-16 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 2017-11-16 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2020-03-27 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 29 | AP | 2022-02-14 | STANDARD |
| LABELING; Labeling | SUPPL | 33 | AP | 2022-07-12 | STANDARD |
| LABELING; Labeling | SUPPL | 34 | AP | 2022-07-27 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 25 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 6 |
CDER Filings
GENENTECH
cder:Array
(
[0] => Array
(
[ApplNo] => 125486
[companyName] => GENENTECH
[docInserts] => ["",""]
[products] => [{"drugName":"GAZYVA","activeIngredients":"OBINUTUZUMAB","strength":"1000MG\/40ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
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[supplements] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-25","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125486s025lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125486Orig1s025ltr.pdf\"}]","notes":">"},{"actionDate":"11\/16\/2017","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125486s017s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125486Orig1s017s018ltr.pdf\"}]","notes":">"},{"actionDate":"11\/16\/2017","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125486s017s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125486Orig1s017s018ltr.pdf\"}]","notes":">"},{"actionDate":"02\/26\/2016","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125486s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125486Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"09\/23\/2015","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125486s010lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125486Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"12\/24\/2014","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125486Orig1s009ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/27\/2014","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125486_s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125486Orig1s008ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-03-27
)
)