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AntidiabeticsSUBCUTANEOUSStandard

FIASP PENFILL

INSULIN ASPART

Standard Dose
300 UNITS/3ML (100 UNITS/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview FIASP PENFILL is listed in Drugs@FDA under application 208751 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN ASPART Form and strength SOLUTION;SUBCUTANEOUS - 300 UNITS/3ML (100 UNITS/ML) Sponsor NOVO Submission history Latest submission status date: 2023-06-21 00:00:00.

Structured Monograph

Clinical summary

Approval overview FIASP PENFILL is listed in Drugs@FDA under application 208751 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN ASPART Form and strength SOLUTION;SUBCUTANEOUS - 300 UNITS/3ML (100 UNITS/ML) Sponsor NOVO Submission history Latest submission status date: 2023-06-21 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.