Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;SUBCUTANEOUS | 1400MG and 23400UNITS/11.7ML | 0 | RITUXAN HYCELA | RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
| 002 | SOLUTION;SUBCUTANEOUS | 1600MG and 26800UNITS/13.4ML | 0 | RITUXAN HYCELA | RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) |
FDA Submissions
| TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2017-06-22 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-12-19 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-05-05 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2021-06-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 10 | Orphan | 5 |
| SUPPL | 13 | Null | 15 |
CDER Filings
GENENTECH INC
cder:Array
(
[0] => Array
(
[ApplNo] => 761064
[companyName] => GENENTECH INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761064s008s010lbl.pdf#page=28"]
[products] => [{"drugName":"RITUXAN HYCELA","activeIngredients":"RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)","strength":"1400MG and 23400UNITS\/11.7ML","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"RITUXAN HYCELA","activeIngredients":"RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)","strength":"1600MG and 26800UNITS\/13.4ML","dosageForm":"SOLUTION;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
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[originalApprovals] => [{"actionDate":"06\/22\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761064Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761064Orig1s000TOC.cfm\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/05\/2020","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761064s008s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761064Orig1s008,s010ltr.pdf\"}]","notes":">"},{"actionDate":"12\/19\/2019","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761064s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761064Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"05\/05\/2020","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761064s008s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761064Orig1s008,s010ltr.pdf\"}]","notes":">"},{"actionDate":"06\/22\/2017","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761064s000lbl.pdf\"}]","notes":">"}]
[actionDate] => 2020-05-05
)
)