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General MedicationsSUBCUTANEOUSStandard

BYNFEZIA PEN

OCTREOTIDE ACETATE

Standard Dose
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview BYNFEZIA PEN is listed in Drugs@FDA under application 213224 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient OCTREOTIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) Sponsor SUN PHARM Submission history Latest submission status date: 2024-09-27 00:00:00.

Structured Monograph

Clinical summary

Approval overview BYNFEZIA PEN is listed in Drugs@FDA under application 213224 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OCTREOTIDE ACETATE Form and strength SOLUTION;SUBCUTANEOUS - EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) Sponsor SUN PHARM Submission history Latest submission status date: 2024-09-27 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.