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General MedicationsSUBCUTANEOUSStandard

SIGNIFOR

PASIREOTIDE DIASPARTATE

Standard Dose
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SIGNIFOR is listed in Drugs@FDA under application 200677 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient PASIREOTIDE DIASPARTATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) Sponsor RECORDATI RARE Submission history Latest submission status date: 2024-07-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview SIGNIFOR is listed in Drugs@FDA under application 200677 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient PASIREOTIDE DIASPARTATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML) Sponsor RECORDATI RARE Submission history Latest submission status date: 2024-07-11 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.