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 217110

IVRA (MELPHALAN HYDROCHLORIDE)
EQ 90MG BASE/ML (EQ 90MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: MELPHALAN HYDROCHLORIDE
Proprietary Name: IVRA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 90MG BASE/ML (EQ 90MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N217110
Product Number: 001
Approval Date: Aug 18, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top