Active Ingredient: PROBENECID; SULOPENEM ETZADROXIL
Proprietary Name: ORLYNVAH
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N213972
Product Number: 001
Approval Date: Oct 25, 2024
Applicant Holder Full Name: ITERUM THERAPEUTICS US LTD
Marketing Status:
Prescription
Patent and Exclusivity Information