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General MedicationsINJECTIONStandard

HYLENEX RECOMBINANT

HYALURONIDASE RECOMBINANT HUMAN

Standard Dose
150 UNITS/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview HYLENEX RECOMBINANT is listed in Drugs@FDA under application 021859 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient HYALURONIDASE RECOMBINANT HUMAN Form and strength INJECTABLE;INJECTION - 150 UNITS/ML Sponsor HALOZYME THERAP Submission history Latest submission status date: 2024-01-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview HYLENEX RECOMBINANT is listed in Drugs@FDA under application 021859 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient HYALURONIDASE RECOMBINANT HUMAN Form and strength INJECTABLE;INJECTION - 150 UNITS/ML Sponsor HALOZYME THERAP Submission history Latest submission status date: 2024-01-12 00:00:00. Submission type: SUPPL.

Monitoring

  • Marketing status: Prescription
  • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.