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General MedicationsINJECTIONStandard

NYPOZI

FILGRASTIM-TXID

Standard Dose
480MCG/0.8ML
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NYPOZI is listed in Drugs@FDA under application 761126 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient FILGRASTIM-TXID Form and strength INJECTABLE;INJECTION - 480MCG/0.8ML Sponsor TANVEX BIOPHARMA USA INC Submission history Latest submission status date: 2024-06-28 00:00:00.

Structured Monograph

Clinical summary

Approval overview NYPOZI is listed in Drugs@FDA under application 761126 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient FILGRASTIM-TXID Form and strength INJECTABLE;INJECTION - 480MCG/0.8ML Sponsor TANVEX BIOPHARMA USA INC Submission history Latest submission status date: 2024-06-28 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.