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General MedicationsTOPICALStandard

SOFDRA

SOFPIRONIUM BROMIDE

Standard Dose
EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview SOFDRA is listed in Drugs@FDA under application 217347 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient SOFPIRONIUM BROMIDE Form and strength GEL, METERED;TOPICAL - EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) Sponsor BOTANIX SB Submission history Latest submission status date: 2024-06-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview SOFDRA is listed in Drugs@FDA under application 217347 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient SOFPIRONIUM BROMIDE Form and strength GEL, METERED;TOPICAL - EQ 12.45% BASE (EQ 72MG BASE/ACTUATION) Sponsor BOTANIX SB Submission history Latest submission status date: 2024-06-18 00:00:00. Submission type: ORIG.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.