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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214801

Marketing Status: Prescription
Active Ingredient: FUTIBATINIB
Proprietary Name: LYTGOBI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214801
Product Number: 001
Approval Date: Sep 30, 2022
Applicant Holder Full Name: TAIHO ONCOLOGY INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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