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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211810

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