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 212991

TOBRAMYCIN AND DEXAMETHASONE (DEXAMETHASONE; TOBRAMYCIN)
0.1%;0.3%
Marketing Status: Discontinued
Active Ingredient: DEXAMETHASONE; TOBRAMYCIN
Proprietary Name: TOBRAMYCIN AND DEXAMETHASONE
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.1%;0.3%
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A212991
Product Number: 001
Approval Date: Jul 15, 2021
Applicant Holder Full Name: AMNEAL EU LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
Back to Top