General MedicationsSUBCUTANEOUSStandard

HERCEPTIN HYLECTA

TRASTUZUMAB AND HYALURONIDASE-OYSK

Standard Dose

600MG;10000UNITS

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview HERCEPTIN HYLECTA is listed in Drugs@FDA under application 761106 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TRASTUZUMAB AND HYALURONIDASE-OYSK Form and strength INJECTABLE;SUBCUTANEOUS - 600MG;10000UNITS Sponsor GENENTECH INC Submission history Latest submission status date: 2024-06-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview HERCEPTIN HYLECTA is listed in Drugs@FDA under application 761106 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient TRASTUZUMAB AND HYALURONIDASE-OYSK Form and strength INJECTABLE;SUBCUTANEOUS - 600MG;10000UNITS Sponsor GENENTECH INC Submission history Latest submission status date: 2024-06-18 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.