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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213972

ORLYNVAH (PROBENECID; SULOPENEM ETZADROXIL)
500MG;500MG
Marketing Status: Prescription
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
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