U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for NDA 217347

SOFDRA (SOFPIRONIUM BROMIDE)
EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)
Marketing Status: Prescription
Active Ingredient: SOFPIRONIUM BROMIDE
Proprietary Name: SOFDRA
Dosage Form; Route of Administration: GEL, METERED; TOPICAL
Strength: EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217347
Product Number: 001
Approval Date: Jun 18, 2024
Applicant Holder Full Name: BOTANIX SB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top