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 021196

Marketing Status: Prescription
Active Ingredient: SODIUM OXYBATE
Proprietary Name: XYREM
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 0.5GM/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021196
Product Number: 001
Approval Date: Jul 17, 2002
Applicant Holder Full Name: JAZZ PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top