Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 761064
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
06/22/2017 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
06/22/2017 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761064s000lbl.pdf

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