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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211192

TIBSOVO (IVOSIDENIB)
250MG
Marketing Status: Prescription
Active Ingredient: IVOSIDENIB
Proprietary Name: TIBSOVO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211192
Product Number: 001
Approval Date: Jul 20, 2018
Applicant Holder Full Name: SERVIER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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