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 ANDA 091135

DEXTROMETHORPHAN POLISTIREX (DEXTROMETHORPHAN POLISTIREX)
EQ 30MG HYDROBROMIDE/5ML
Marketing Status: Over-the-counter
Active Ingredient: DEXTROMETHORPHAN POLISTIREX
Proprietary Name: DEXTROMETHORPHAN POLISTIREX
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; ORAL
Strength: EQ 30MG HYDROBROMIDE/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A091135
Product Number: 001
Approval Date: May 25, 2012
Applicant Holder Full Name: TRIS PHARMA INC
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
Back to Top