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 NDA 202292

MYTESI (CROFELEMER)
125MG
Marketing Status: Prescription
Active Ingredient: CROFELEMER
Proprietary Name: MYTESI
Dosage Form; Route of Administration: TABLET, DELAYED RELEASE; ORAL
Strength: 125MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202292
Product Number: 001
Approval Date: Dec 31, 2012
Applicant Holder Full Name: NAPO PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top