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 208272

ROFLUMILAST (ROFLUMILAST)
500MCG
Marketing Status: Discontinued
Active Ingredient: ROFLUMILAST
Proprietary Name: ROFLUMILAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A208272
Product Number: 001
Approval Date: Aug 6, 2018
Applicant Holder Full Name: TORRENT PHARMACEUTICALS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top