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 216974

XACDURO (COPACKAGED) (DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM)
EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
Marketing Status: Prescription
Active Ingredient: DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM
Proprietary Name: XACDURO (COPACKAGED)
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216974
Product Number: 001
Approval Date: May 23, 2023
Applicant Holder Full Name: ENTASIS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top