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 078964

RABEPRAZOLE SODIUM (RABEPRAZOLE SODIUM)
20MG
Marketing Status: Prescription
Active Ingredient: RABEPRAZOLE SODIUM
Proprietary Name: RABEPRAZOLE SODIUM
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078964
Product Number: 001
Approval Date: Nov 8, 2013
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top