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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208794

XERMELO (TELOTRISTAT ETIPRATE)
EQ 250MG BASE
Marketing Status: Prescription
Active Ingredient: TELOTRISTAT ETIPRATE
Proprietary Name: XERMELO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 250MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208794
Product Number: 001
Approval Date: Feb 28, 2017
Applicant Holder Full Name: TERSERA THERAPEUTICS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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