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 022503

METAXALONE (METAXALONE)
640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METAXALONE
Proprietary Name: METAXALONE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 640MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022503
Product Number: 001
Approval Date: Jun 1, 2015
Applicant Holder Full Name: PRIMUS PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top