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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 211801

IBSRELA (TENAPANOR HYDROCHLORIDE)
EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: TENAPANOR HYDROCHLORIDE
Proprietary Name: IBSRELA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N211801
Product Number: 001
Approval Date: Sep 12, 2019
Applicant Holder Full Name: ARDELYX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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