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 205457

BUDESONIDE (BUDESONIDE)
9MG
Marketing Status: Prescription
Active Ingredient: BUDESONIDE
Proprietary Name: BUDESONIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 9MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A205457
Product Number: 001
Approval Date: Jul 3, 2018
Applicant Holder Full Name: ACTAVIS LABORATORIES FL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top