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AntidiabeticsSUBCUTANEOUSStandard

NOVOLOG MIX 70/30 FLEXPEN

INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT

Standard Dose
210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NOVOLOG MIX 70/30 FLEXPEN is listed in Drugs@FDA under application 021172 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT Form and strength INJECTABLE;SUBCUTANEOUS - 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) Sponsor NOVO NORDISK INC Submission history Latest submission status date: 2023-02-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview NOVOLOG MIX 70/30 FLEXPEN is listed in Drugs@FDA under application 021172 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT Form and strength INJECTABLE;SUBCUTANEOUS - 210 UNITS/3ML; 90 UNITS/3ML (70 UNITS/ML; 30 UNITS/ML) Sponsor NOVO NORDISK INC Submission history Latest submission status date: 2023-02-28 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.