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 211673

XENLETA (LEFAMULIN ACETATE)
EQ 150MG BASE/15ML (EQ 10MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: LEFAMULIN ACETATE
Proprietary Name: XENLETA
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: EQ 150MG BASE/15ML (EQ 10MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211673
Product Number: 001
Approval Date: Aug 19, 2019
Applicant Holder Full Name: NABRIVA THERAPEUTICS IRELAND DAC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top