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General MedicationsSUBCUTANEOUSStandard

NPLATE

ROMIPLOSTIM

Standard Dose
250MCG/0.5ML; 500MCG/1ML.
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview NPLATE is listed in Drugs@FDA under application 125268 (BLA).

Review priority: STANDARD Marketing status: Prescription Active ingredient ROMIPLOSTIM Form and strength INJECTABLE; SUBCUTANEOUS - 250MCG/0.5ML; 500MCG/1ML.

Structured Monograph

Clinical summary

Approval overview NPLATE is listed in Drugs@FDA under application 125268 (BLA). Review priority: STANDARD Marketing status: Prescription Active ingredient ROMIPLOSTIM Form and strength INJECTABLE; SUBCUTANEOUS - 250MCG/0.5ML; 500MCG/1ML. Sponsor AMGEN Submission history Latest submission status date: 2025-02-21 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.