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 204658

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE (HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE)
5MG/5ML;60MG/5ML
Marketing Status: Discontinued
Active Ingredient: HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
Proprietary Name: HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 5MG/5ML;60MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A204658
Product Number: 001
Approval Date: Apr 29, 2014
Applicant Holder Full Name: PADAGIS US LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top