General MedicationsSUBCUTANEOUSStandard

RITUXAN HYCELA

RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT)

Standard Dose

1600MG and 26800UNITS/13.4ML

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview RITUXAN HYCELA is listed in Drugs@FDA under application 761064 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) Form and strength SOLUTION;SUBCUTANEOUS - 1600MG and 26800UNITS/13.4ML Sponsor GENENTECH INC Submission history Latest submission status date: 2021-06-10 00:00:00.

Structured Monograph

Clinical summary

Approval overview RITUXAN HYCELA is listed in Drugs@FDA under application 761064 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient RITUXIMAB; HYALURONIDASE (HUMAN RECOMBINANT) Form and strength SOLUTION;SUBCUTANEOUS - 1600MG and 26800UNITS/13.4ML Sponsor GENENTECH INC Submission history Latest submission status date: 2021-06-10 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.