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 211349

XOSPATA (GILTERITINIB FUMARATE)
EQ 40MG BASE
Marketing Status: Prescription
Active Ingredient: GILTERITINIB FUMARATE
Proprietary Name: XOSPATA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 40MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211349
Product Number: 001
Approval Date: Nov 28, 2018
Applicant Holder Full Name: ASTELLAS PHARMA US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top