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General MedicationsINTRATRACHEALStandard

INFASURF PRESERVATIVE FREE

CALFACTANT

Standard Dose
35MG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview INFASURF PRESERVATIVE FREE is listed in Drugs@FDA under application 020521 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CALFACTANT Form and strength SUSPENSION;INTRATRACHEAL - 35MG/ML Sponsor ONY Submission history Latest submission status date: 2024-08-23 00:00:00.

Structured Monograph

Clinical summary

Approval overview INFASURF PRESERVATIVE FREE is listed in Drugs@FDA under application 020521 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient CALFACTANT Form and strength SUSPENSION;INTRATRACHEAL - 35MG/ML Sponsor ONY Submission history Latest submission status date: 2024-08-23 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.