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 076751

MESALAMINE (MESALAMINE)
4GM/60ML
Marketing Status: Prescription
Active Ingredient: MESALAMINE
Proprietary Name: MESALAMINE
Dosage Form; Route of Administration: ENEMA; RECTAL
Strength: 4GM/60ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A076751
Product Number: 001
Approval Date: Sep 17, 2004
Applicant Holder Full Name: PADAGIS ISRAEL PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top