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 200963

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE (CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE)
10MG/5ML;5MG/5ML;6.25MG/5ML
Marketing Status: Prescription
Active Ingredient: CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Proprietary Name: PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
Dosage Form; Route of Administration: SYRUP; ORAL
Strength: 10MG/5ML;5MG/5ML;6.25MG/5ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AA
Application Number: A200963
Product Number: 001
Approval Date: Aug 26, 2015
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top