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 215239

AGAMREE (VAMOROLONE)
40MG/ML
Marketing Status: Prescription
Active Ingredient: VAMOROLONE
Proprietary Name: AGAMREE
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 40MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215239
Product Number: 001
Approval Date: Oct 26, 2023
Applicant Holder Full Name: CATALYST PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top