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General MedicationsSINGLE-DOSEStandard

NIVESTYM

FILGRASTIM-AAFI

Standard Dose
300MCG/ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NIVESTYM is listed in Drugs@FDA under application 761080 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FILGRASTIM-AAFI Form and strength VIAL;SINGLE-DOSE - 300MCG/ML Sponsor HOSPIRA INC Submission history Latest submission status date: 2024-02-16 00:00:00.

Structured Monograph

Clinical summary

Approval overview NIVESTYM is listed in Drugs@FDA under application 761080 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient FILGRASTIM-AAFI Form and strength VIAL;SINGLE-DOSE - 300MCG/ML Sponsor HOSPIRA INC Submission history Latest submission status date: 2024-02-16 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.