Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761064
Company: GENENTECH INC
Company: GENENTECH INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RITUXAN HYCELA | RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) | 1400MG and 23400UNITS/11.7ML | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
RITUXAN HYCELA | RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) | 1600MG and 26800UNITS/13.4ML | SOLUTION;SUBCUTANEOUS | 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 |
---|---|---|---|---|---|---|---|
06/22/2017 | ORIG-1 | Approval | N/A; Orphan |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761064Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761064Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
06/10/2021 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761064s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761064Orig1s013ltr.pdf | |
05/05/2020 | SUPPL-10 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761064s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761064Orig1s008,s010ltr.pdf | |
12/19/2019 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761064s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761064Orig1s009ltr.pdf | |
05/05/2020 | SUPPL-8 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761064s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761064Orig1s008,s010ltr.pdf | |
06/22/2017 | SUPPL-1 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
06/10/2021 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761064s013lbl.pdf | |
05/05/2020 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761064s008s010lbl.pdf | |
05/05/2020 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761064s008s010lbl.pdf | |
05/05/2020 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761064s008s010lbl.pdf | |
12/19/2019 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761064s009lbl.pdf | |
06/22/2017 | SUPPL-1 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf |