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 211810

Expand all

TURALIO (PEXIDARTINIB HYDROCHLORIDE)
EQ 125MG BASE
Marketing Status: Prescription
Active Ingredient: PEXIDARTINIB HYDROCHLORIDE
Proprietary Name: TURALIO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 125MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N211810
Product Number: 002
Approval Date: Oct 14, 2022
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
TURALIO (PEXIDARTINIB HYDROCHLORIDE)
EQ 200MG BASE
Marketing Status: Prescription
Active Ingredient: PEXIDARTINIB HYDROCHLORIDE
Proprietary Name: TURALIO
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211810
Product Number: 001
Approval Date: Aug 2, 2019
Applicant Holder Full Name: DAIICHI SANKYO INC
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top