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 210326

FULVESTRANT (FULVESTRANT)
250MG/5ML (50MG/ML)
Marketing Status: Prescription
Active Ingredient: FULVESTRANT
Proprietary Name: FULVESTRANT
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR
Strength: 250MG/5ML (50MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AO
Application Number: N210326
Product Number: 001
Approval Date: May 20, 2019
Applicant Holder Full Name: FRESENIUS KABI USA LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top