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 216165

EXBLIFEP (CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM)
EQ 2GM BASE/VIAL;0.5GM/VIAL
Marketing Status: Prescription
Active Ingredient: CEFEPIME HYDROCHLORIDE; ENMETAZOBACTAM
Proprietary Name: EXBLIFEP
Dosage Form; Route of Administration: POWDER; INTRAVENOUS
Strength: EQ 2GM BASE/VIAL;0.5GM/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216165
Product Number: 001
Approval Date: Feb 22, 2024
Applicant Holder Full Name: ALLECRA THERAPEUTICS SAS
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top