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AntidiabeticsINTRAVENOUS, SUBCUTANEOUSStandard

APIDRA

INSULIN GLULISINE RECOMBINANT

Standard Dose
1000 UNITS/10ML (100 UNITS/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview APIDRA is listed in Drugs@FDA under application 021629 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLULISINE RECOMBINANT Form and strength INJECTABLE;INTRAVENOUS, SUBCUTANEOUS - 1000 UNITS/10ML (100 UNITS/ML) Sponsor SANOFI AVENTIS US Submission history Latest submission status date: 2022-11-30 00:00:00.

Structured Monograph

Clinical summary

Approval overview APIDRA is listed in Drugs@FDA under application 021629 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient INSULIN GLULISINE RECOMBINANT Form and strength INJECTABLE;INTRAVENOUS, SUBCUTANEOUS - 1000 UNITS/10ML (100 UNITS/ML) Sponsor SANOFI AVENTIS US Submission history Latest submission status date: 2022-11-30 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.