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 215430

AUVELITY (BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE)
105MG;45MG
Marketing Status: Prescription
Active Ingredient: BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Proprietary Name: AUVELITY
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 105MG;45MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215430
Product Number: 001
Approval Date: Aug 18, 2022
Applicant Holder Full Name: AXSOME THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top