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 208236

Expand all

ROFLUMILAST (ROFLUMILAST)
250MCG
Marketing Status: Prescription
Active Ingredient: ROFLUMILAST
Proprietary Name: ROFLUMILAST
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MCG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208236
Product Number: 002
Approval Date: Oct 19, 2023
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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: A208236
Product Number: 001
Approval Date: Oct 3, 2018
Applicant Holder Full Name: BRECKENRIDGE PHARMACEUTICAL INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top