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General MedicationsINJECTIONStandard

NAGLAZYME

GALSULFASE

Standard Dose
5MG/5ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NAGLAZYME is listed in Drugs@FDA under application 125117 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient GALSULFASE Form and strength INJECTABLE; INJECTION - 5MG/5ML Sponsor BIOMARIN Submission history Latest submission status date: 2024-09-12 00:00:00.

Structured Monograph

Clinical summary

Approval overview NAGLAZYME is listed in Drugs@FDA under application 125117 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient GALSULFASE Form and strength INJECTABLE; INJECTION - 5MG/5ML Sponsor BIOMARIN Submission history Latest submission status date: 2024-09-12 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.