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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761064
Company: GENENTECH INC

Medication Guide

Products on BLA 761064

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761064

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

Labels for BLA 761064

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

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